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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 33.

Covidien LLC - Monoject Insulin Safety Syringe 1/2mL 29 X 1/2 - Class 2 Recall
Monoject Insulin Safety Syringe 1/2mL 29 X 1/2" Product ID: 8881511136 Indications for Use: Injection of U-1 00 insulin
Source: Medical Device Recalls - May 31, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance iCT and iCT SP - Class 2 Recall
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance 16 Computed Tomography XRay Scanning System - Class 2 Recall
Brilliance 16 - Model #728246, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment , patient, and equipment supports, components and accessories.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore Computed Tomography XRay Scanning Systems - Class 2 Recall
Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment , patient, and equipment supports, components and accessories.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - e.cam Emission Computed Tomography Systems - Class 2 Recall
e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance 40 and Brilliance 64 and Ingenuity Computed Tomography XRay Scanning Systems - Class 2 Recall
Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model #728326, CT Scanning Systems are subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment , patient, and equipment supports, components and accessories.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Symbia E Series SPECT System - Class 2 Recall
Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for planar imaging, whole-body scans, and SPECT studies.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Imaging - Class 2 Recall
Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance iCT and Brilliance iCT SP Computed Tomography XRay Scanning Systems - Class 2 Recall
Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment , patient, and equipment supports, components and accessories.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

CaridianBCT, Inc. - Terumo BCT - Class 2 Recall
Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

MOOG Medical Devices Group - Curlin Infusion Administration Set - Class 1 Recall
Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product code: 340-4128, Method of Sterilization using Ethylene Oxide. The Curlin¿ Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Siemens brand ACUSON S2000 Ultrasound Systemsand the Advanced SieClearTM spatial, - Class 2 Recall
Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 - ACUSON S2000 Mainframe; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, ...
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial - Class 2 Recall
Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10440017 - ACUSON S2000 Refurb. Mainframe; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in ...
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

ConMed Electrosurgery - Altrus Energy Source - Class 2 Recall
Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd, Utica, NY 13502, MDSS GmbH, Germany. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
Source: Medical Device Recalls - May 29, 2012 Category: Medical Equipment Source Type: alerts

Alphatec Spine, Inc. - Alphatec Souls Proximal/Distal Deployment Wrench - Class 2 Recall
SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative t...
Source: Medical Device Recalls - May 29, 2012 Category: Medical Equipment Source Type: alerts

ConMed Electrosurgery - Altrus Thermal Tissue Fusion - Class 2 Recall
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 36 cm Shaft, Catalog Number 60-9522-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
Source: Medical Device Recalls - May 29, 2012 Category: Medical Equipment Source Type: alerts

Stryker Howmedica Osteonics Corp. - Restoration HA Reduced Neck - Class 2 Recall
Restoration HA Reduced Neck 25 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Restoration HA cementless Hip System is designed to address the problems of revision surgery where extensive fixation both distally and proximally is required for support of the prosthesis. A comprehensive size range mates a variety of proximal cross sections and lengths with 10 distal cylindrical diameters to provide for patient matched sizing in revision circumstances. The stem design incorporates a physiologic 127 degree neck stem angle, neck length ranges and a C-Taper head to provide...
Source: Medical Device Recalls - May 29, 2012 Category: Medical Equipment Source Type: alerts

Water Pik, Inc. - Waterpik - Class 2 Recall
Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.
Source: Medical Device Recalls - May 25, 2012 Category: Medical Equipment Source Type: alerts

Baxa Corporation - Abacus TPN Calculating Software - Class 1 Recall
Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.
Source: Medical Device Recalls - May 25, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System - Class 2 Recall
Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product Usage: Nuclear magnetic resonance imaging
Source: Medical Device Recalls - May 25, 2012 Category: Medical Equipment Source Type: alerts

Ethicon Endo-Surgery Inc - HARMONIC Blue Hand Piece & HARMONIC Hand Piece - Class 2 Recall
HPBLUE: HARMONIC¿ Blue Hand Piece; HP054: HARMONIC¿ Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo, PR 00969. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
Source: Medical Device Recalls - May 25, 2012 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Co. - BD Phoenix Automated Microbiology System Software for Automated Microbiological System - Class 2 Recall
Becton Dickinson Phoenix" System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Positive bacteria from pure culture.
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Co. - BD Phoenix System software update disk - Class 2 Recall
Becton Dickinson Phoenix" Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: This update disk was an interim corrective action recommended by FDA to be installed in Phoenix instruments so that test results associated with E.faecium susceptibility can not be printed by the labs until a final algorithm correction (change) is implemented by the firm
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

Vascular Solutions, Inc. - GuideLiner V2 Catheter - Class 2 Recall
Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices.
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

Apheresis Technologies, Inc. - PlasmaPro Plasma Pump - Class 2 Recall
PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

Cincinnati Sub-Zero Products Inc - Cardiopulmonary bypass temperature controllers - Class 2 Recall
ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass temperature controllers. The ECMO Heaters are used in conjunction with a heat exchanger to warm the fluid temperature. The device is composed of a heater, a circulating pump, fan, safety high limit, and a microprocessor board. Water is heated and pumped from the unit to the heat exchanger. The device can be set so that the operator can monitor the actual water temperature or, with the use of a 400 series probe, the fluid (external) temperature. This device is intended to provide temperature-controlled warm water flow t...
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

Pharmaceutical Innovations, Inc. - OtherSonic Generic Ultrasound Transmission Gel - Class 1 Recall
Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

Pharmaceutical Innovations, Inc. - OtherSonic Generic Ultrasound Transmission Gel - Class 1 Recall
Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
Source: Medical Device Recalls - May 24, 2012 Category: Medical Equipment Source Type: alerts

College Park Industries, Inc. - Celsus Foot - Class 2 Recall
Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.
Source: Medical Device Recalls - May 23, 2012 Category: Medical Equipment Source Type: alerts

Captiva Spine, Inc - Accessories for the Captiva Spine SmartLOX Cervical Plate System. - Class 2 Recall
Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number 06110041***" "***Part Number CP50160***Single Barrel Fixed Drill Guide***Lot Number 1500707A or Lot Number 06110043***" "***Part Number CP50170***Double Barrel Fixed Drill Guide***Lot Number 1500708A or Lot Number 06110044***" Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray. The Captiva Spine SmartLOX Cervical Pla...
Source: Medical Device Recalls - May 23, 2012 Category: Medical Equipment Source Type: alerts

Captiva Spine, Inc - Drill Bits for Cervical Plate System - Class 2 Recall
Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
Source: Medical Device Recalls - May 23, 2012 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Linear Accelerator - Class 2 Recall
MLCi/MCLi2. Radiation therapy.
Source: Medical Device Recalls - May 23, 2012 Category: Medical Equipment Source Type: alerts

Computerized Medical Systems Inc - XiO Radiation Treatment Planning System - Class 2 Recall
XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Source: Medical Device Recalls - May 22, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Ingenuity TF PET/MRI System - Class 2 Recall
Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imagi...
Source: Medical Device Recalls - May 22, 2012 Category: Medical Equipment Source Type: alerts