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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 23.

GE OEC Medical Systems, Inc - OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak P - Class 1 Recall
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
Source: Medical Device Recalls - August 28, 2012 Category: Medical Equipment Source Type: alerts

Advanced Neuromodulation Systems Inc. - Eon Mini - Class 2 Recall
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Source: Medical Device Recalls - August 28, 2012 Category: Medical Equipment Source Type: alerts

Advanced Neuromodulation Systems Inc. - Eon - Class 2 Recall
Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Source: Medical Device Recalls - August 28, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Siemens Stratus(R) CS Acute Care(TM) Ddimer Calibrator (DDM CalPak) - Class 3 Recall
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method
Source: Medical Device Recalls - August 28, 2012 Category: Medical Equipment Source Type: alerts

Unimed Surgical Products, Inc. - Mediline Industries, Inc. - Class 2 Recall
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0012M -- Lot # 030509-07, 052909-02, 062309-02. Product Usage: Intended for cutting and coagulation of soft tissue.
Source: Medical Device Recalls - August 28, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - syngo.plaza - Class 2 Recall
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Source: Medical Device Recalls - August 27, 2012 Category: Medical Equipment Source Type: alerts

Advanced Sterilization Products - CIDEX OPA - Class 2 Recall
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Source: Medical Device Recalls - August 27, 2012 Category: Medical Equipment Source Type: alerts

Bard Access Systems - HemoStar XK LongTerm Hemodialysis Catheter - Class 3 Recall
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.
Source: Medical Device Recalls - August 27, 2012 Category: Medical Equipment Source Type: alerts

Atlas Spine, Inc. - Apelo Modular Screwdriver for Apelo Pedicle Screw System - Class 2 Recall
Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.
Source: Medical Device Recalls - August 27, 2012 Category: Medical Equipment Source Type: alerts

Alphatec Spine, Inc. - TRESTLE LUXE Anterior Cervical Plating System - Class 2 Recall
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondy...
Source: Medical Device Recalls - August 27, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - syngo Imaging XS - Class 2 Recall
syngo Imaging XS. Radiological image processing system.
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Canon Inc. - Digital Radiography, CXDI - Class 2 Recall
Canon Solid Stale X-ray Imaqer (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Cisco Systems Inc - Class 2 Recall
Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use i...
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Sunquest Information Systems, Inc. - Sunquest Laboratory LabAccess Results Workstation - Class 2 Recall
Sunquest Laboratory LabAccess Results Workstation (LARS)
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Biomet 3i, LLC - Low Profile Abutment - Class 2 Recall
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Metrex Research, LLC. - CaviCide - Class 2 Recall
CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bott...
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Sunquest Information Systems, Inc. - Sunquest Laboratory Versions 6.4 - Class 2 Recall
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - MiniInfuser Model 150XL Infusion Pump - Class 3 Recall
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - MiniInfuser Model 300XL Multispeed Infusion Pump - Class 3 Recall
Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - Scanner, Computed Tomography, XRay - Class 2 Recall
Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metast...
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Galil Medical, Inc. - VisualICE Cryoablation System - Class 2 Recall
Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesion...
Source: Medical Device Recalls - August 23, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. - Class 2 Recall
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
Source: Medical Device Recalls - August 23, 2012 Category: Medical Equipment Source Type: alerts

Hitachi Medical Systems America Inc - Echelon and Oasis - Class 2 Recall
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.
Source: Medical Device Recalls - August 23, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - UniCel DxI and DXC Immunoassay Systems - Class 2 Recall
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Source: Medical Device Recalls - August 23, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - OEC InstaTrak 3500 - Class 2 Recall
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
Source: Medical Device Recalls - August 22, 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

AGFA Corp. - AGFA DICOMStore - Class 2 Recall
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance 6, 10, 16, 40, 64 and CT Big Bore - Class 2 Recall
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore 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 - August 22, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - EasyLink(TM) Informatics System included with the Dimension Vista System - Class 2 Recall
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. The EasyLink Informatics System is classified as a data calculator and processing module for use with in vitro diagnostic devices. The EasyLink is included with the Dimension Vista System and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with lab...
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes - Class 2 Recall
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

Abbott Point Of Care Inc. - iSTAT cTnI cartridges - Class 2 Recall
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

Sunquest Information Systems, Inc. - Sunquest Encompass - Class 3 Recall
Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

Mckesson Medical Imaging Group - Horizon Medical Imaging system. - Class 2 Recall
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other com...
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Positron Emission Tomography (PET) and Xray Computed Tomography - Class 2 Recall
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, he...
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

Medtronic Navigation, Inc. - Medtronic Oarm Imaging System - Class 2 Recall
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - GE OEC 9800 - Class 2 Recall
892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and are also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The systems may be used for other imaging applications at the physician's discretion.
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

Stryker Medical Division of Stryker Corporation - Powered Mobility Offers Versatility (MV)TM Chair1 - Class 2 Recall
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts