Medical Equipment 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. This is page number 9.

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare ADVIA Centaur Folate (FOL) - Class 2 Recall
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.
Source: Medical Device Recalls - December 11, 2012 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - Mindray DS USA Inc. - Class 2 Recall
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) a...
Source: Medical Device Recalls - December 11, 2012 Category: Medical Equipment Source Type: alerts

Covidien LLC dba Uni-Patch - Reusable, SelfAdhering TENS/NMES/FES electrodes - Class 2 Recall
Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

Parks Medical Electronics, Inc - Cardiovascular blood flowmeter - Class 2 Recall
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

Covidien LLC dba Uni-Patch - Performa reusable and selfadhering TENS/NMES/FES stimulating electrodes, - Class 2 Recall
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

Covidien LLC dba Uni-Patch - Empi STIMC RE Self Adhesive electrodes - Class 2 Recall
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

Covidien LLC dba Uni-Patch - Reusable, nonsterile, selfadhering electrodes for use with TENS/NMES - Class 2 Recall
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX - Class 2 Recall
Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuratio...
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall
WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

Hospira Inc. - Plum A Single Channel Infusion Pumps with MedNet Software - Class 2 Recall
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list #20679 and 20792, module list number 20677. The Plum A+ Infusion System with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable t...
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Hospira Inc. - Plum A Hyperbaric Single Channel Infusion Pumps - Class 2 Recall
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Hospira Inc. - Plum A Single Channel Infusion Pumps - Class 2 Recall
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680 Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Verathon, Inc. - The GlideScope Video Laryngoscope (GVL) GVL 3, GVL4, GVL5 - Class 1 Recall
The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3 0574-0007, GVL 4 0574-0001, and GVL 5 0574-0030. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - Instrument Manager - Class 2 Recall
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - cobas Integra 400/400 Plus - Class 2 Recall
cobas¿ Integra 400/400 Plus (Software version 3.4) The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - LightCycler 1.2 - Class 2 Recall
Roche Molecular Biochemicals LightCycler 1.2 with software version 3.5. LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - MagNA Pure 96 System - Class 2 Recall
Roche MagNA Pure 96 System Version 1.0 (Software Version 2.0) for in vitro diagnostic use. The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - DataCare GM - Class 2 Recall
DataCare GM DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - DataCare POC - Class 2 Recall
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - LightCycler 2.0 - Class 2 Recall
Roche LightCycler 2.0 Instrument with software version 4.1. LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - cobas 8000 modular analyzer series - Class 2 Recall
cobas¿ 8000 modular analyzer series The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - AMPLILINK - Class 2 Recall
AMPLILINK software, For use with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument AMPLILINK software is used to integrate all instruments and analyzers offering a single user interface for PCR testing.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - MagNA Pure LC - Class 2 Recall
Roche Applied Science MagNA Pure LC Version 3.0. The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Mobilette Mira - Class 2 Recall
Siemens Mobilette Mira, intended use as Mobile x-ray system.
Source: Medical Device Recalls - December 6, 2012 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - OSS Knee Reamer Sleeves - Class 2 Recall
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Source: Medical Device Recalls - December 5, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Digital Diagnost R2.0.2 - Class 2 Recall
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Source: Medical Device Recalls - December 5, 2012 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Cobas 8000 Modular Analyzer Series - Class 2 Recall
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
Source: Medical Device Recalls - December 4, 2012 Category: Medical Equipment Source Type: alerts

Philips And Neusoft Medical Systems Co., Ltd. - NeuViz 16 MultiSliced CT Scanner System and NeuViz Dual series CT Scanner System - Class 2 Recall
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
Source: Medical Device Recalls - December 4, 2012 Category: Medical Equipment Source Type: alerts

Invivo Corporation - Invivo Corporation Expression MRI Patient Monitoring System - Class 2 Recall
Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
Source: Medical Device Recalls - December 4, 2012 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - OSS Reamer Sleeve - Class 2 Recall
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Source: Medical Device Recalls - December 4, 2012 Category: Medical Equipment Source Type: alerts

iwalk inc - BiOMBiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium - Class 2 Recall
BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
Source: Medical Device Recalls - December 4, 2012 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - OSS Reamer Sleeve - Class 2 Recall
OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Source: Medical Device Recalls - December 4, 2012 Category: Medical Equipment Source Type: alerts

Stryker Howmedica Osteonics Corp. - Class 2 Recall
Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, co...
Source: Medical Device Recalls - December 4, 2012 Category: Medical Equipment Source Type: alerts

OmniGuide, Inc. - OmniGuide BPROBOTIC - Class 2 Recall
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colon...
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Siemens Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) - Class 2 Recall
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens syngo.plaza Radiological Image Processing System - Class 2 Recall
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Soft Flow Aortic Cannulae - Class 2 Recall
24 Fr 8mm Sft Flow Straight The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Sekisui Diagnostics Llc - Sekisui Diagnostics, Spectrolyse PAI1 catalog 101201 - Class 2 Recall
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Soft Flow Aortic Cannulae - Class 2 Recall
24 Fr 8mm Sft Flow Straight Wir The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Merit Medical Systems, Inc. - Custom Procedural Trays - Class 2 Recall
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Neptune 2 Rover Ultra - Class 2 Recall
Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rover s collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as we...
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts