Anatomy Alerts This is an OPML file. It can be used to export all the MedWorm RSS feeds on this topic into your personal RSS reader (usually you have to save this file to your own computer before clicking on an Import OPML command in your own feed reader to upload the file which will then import all the feeds) or it can be used by webmasters to integrate MedWorm feeds with their own website. This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

This page shows you the most recent publications within this specialty of the MedWorm directory.

GE Healthcare, LLC - GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innov - Class 2 Recall
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Class 2 Recall
GE Healthcare Infinia / Infinia vc Hawkey 4 and Infinia / Infinia vc . Recall includes all Infinia systems, all configurations. Product Usage: K022960 The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tom...
Source: Medical Device Recalls - April 10, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Advantage Workstation - Class 2 Recall
Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(version6.0 to version6.11) and only when one or both of these applications is installed: " CardIQ Xpress Pro or Plus " CardEP Advantage Workstations AW Volume Share 2 (AW version 4.4). ONLY IF ONE OF FOLL...
Source: Medical Device Recalls - December 19, 2012 Category: Medical Equipment Source Type: alerts

OrthoPediatrics Corp - 4.5mm PLEO Osteotomy Guide. - Class 2 Recall
4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc¿ Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc¿ system. The PediLoc¿ Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc¿ Extension Osteotomy Plate is designed to fit the anatomy ...
Source: Medical Device Recalls - November 22, 2012 Category: Medical Equipment Source Type: alerts

Mako Surgical Corporation - The RIO (TGS 2.), - Class 2 Recall
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA...
Source: Medical Device Recalls - November 19, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare innova 3131IQ - Class 2 Recall
GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare innova 3100IQ - Class 2 Recall
GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare innova 3100 - Class 2 Recall
GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2012 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - TSX301A/2 Aquilion One CT System - Class 2 Recall
TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 27, 2012 Category: Medical Equipment Source Type: alerts

Hologic, Inc. - Hologic Fluoroscan Mini CArm Model with InSight2 - Class 2 Recall
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2012 Category: Medical Equipment Source Type: alerts

Hologic, Inc. - Hologic Fluoroscan Mini CArm Model with InSight FD - Class 2 Recall
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular Xray imaging systems. - Class 2 Recall
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography app...
Source: Medical Device Recalls - September 13, 2012 Category: Medical Equipment Source Type: alerts

Stryker Spine - Stryker TRIO/TRIO - Class 2 Recall
Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. The Stryker Spine Trio/Trio+ Spinal Fixation Systems are comprised of spinal screws, rods, and connectors. The components are available in a variety of lengths in order to accomm...
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - Fluoroscopic XRay System - Class 2 Recall
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2012 Category: Medical Equipment Source Type: alerts

General Electric Med Systems LLC - Revolution XR/d - Class 2 Recall
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 8, 2012 Category: Medical Equipment Source Type: alerts

General Electric Med Systems LLC - Silhouette FC (currently marketed as Proteus XR/a) - Class 2 Recall
GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 8, 2012 Category: Medical Equipment Source Type: alerts

General Electric Med Systems LLC - Definium 8000 - Class 2 Recall
GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 8, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare Innova - Class 2 Recall
GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS - Class 2 Recall
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Definium 8000 - Class 2 Recall
GE Healthcare Definium 8000, Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Discovery XR650 - Class 2 Recall
GE Healthcare Discovery XR650, Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Ingenia 1.5T and 3.0T MRI Systems - Class 2 Recall
Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted...
Source: Medical Device Recalls - November 28, 2011 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Symbia S Series SPECT System - Class 2 Recall
Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 23, 2011 Category: Medical Equipment Source Type: alerts

Mako Surgical Corporation - RIO Robot Arm Interactive Orthopedic System - Class 2 Recall
Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995 UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 DAVIE ROAD, FT. LAUDERDALE, FL 33317. RIO System - The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during...
Source: Medical Device Recalls - November 1, 2011 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Innova 3100IQ (Optima Edition) Fluoroscopic Vascular Xray System - Class 2 Recall
GE Healthcare, Innova¿ 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging-procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 28, 2011 Category: Medical Equipment Source Type: alerts

ACell, Inc - MatriStem Plastic Surgery Matrix XS, - Class 2 Recall
MatriStem¿ Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal anatomy, including, but not limited to the following procedures: pubourethral support, tissue repair, body wall repair, and esophageal repair (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2011 Category: Medical Equipment Source Type: alerts

American Medical Systems, Inc. - Elevate Anterior and Apical Prolapse Repair Systems - Class 2 Recall
Elevate¿ System with IntePro¿ Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA Product Usage: The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenteriological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wal...
Source: Medical Device Recalls - July 7, 2011 Category: Medical Equipment Source Type: alerts

Mako Surgical Corporation - MAKO PN 204588 Camera - Class 2 Recall
MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderd...
Source: Medical Device Recalls - May 20, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 39, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 47, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 61, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 55, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
TOTAL ASR FEM IMP SIZE 41, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixat...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 53, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 57, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
TOTAL ASR FEM IMP SIZE 43, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixat...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 51, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
TOTAL ASR FEM IMP SIZE 45, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixat...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 63, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 59, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 49, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Medtronic Navigation, Inc - Surgical Navigation System - Class 2 Recall
Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2011 Category: Medical Equipment Source Type: alerts

Vital Images, Inc. - Vital Connect - Class 2 Recall
Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each oth...
Source: Medical Device Recalls - February 2, 2011 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE - Class 2 Recall
Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained t...
Source: Medical Device Recalls - November 17, 2010 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. - Class 2 Recall
Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier tec...
Source: Medical Device Recalls - November 17, 2010 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Innova 2121IQ/31311Q Biplane Cardiovascular Imaging System - Class 2 Recall
Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, di...
Source: Medical Device Recalls - November 17, 2010 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Innova 2100IQ (The Digital Fluoroscopic Imaging System) - Class 2 Recall
Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intende...
Source: Medical Device Recalls - November 17, 2010 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Innova 2000 - Class 2 Recall
Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These system can be operated in a mobile or fixed site environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2010 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Innova 4100 - Class 2 Recall
Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier tec...
Source: Medical Device Recalls - November 16, 2010 Category: Medical Equipment Source Type: alerts

Ge Healthcare, Llc - Innova 4100/4100IQ with InnovaIQ Table Option - Class 2 Recall
Innova 4100/4100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - June 29, 2010 Category: Medical Equipment Source Type: alerts