Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal...
Reason: Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility ...
Z-0750-2013February 6, 2013Saint Paul, MN
Roche Diagnostics Operations, Inc.
Class IIITerminated
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Reason: A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Li...
Z-0696-2013January 30, 2013Indianapolis, IN
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Bri...
Reason: Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues det...
Z-0674-2013January 23, 2013Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography ...
Reason: Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image ...
Z-0675-2013January 23, 2013Cleveland, OH
Horiba Instruments, Inc dba Horiba Medical
Class IITerminated
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Reason: Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmi...
Z-0645-2013January 16, 2013Irvine, CA
Hospira Inc.
Class IITerminated
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391...
Reason: The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the remov...
Z-0624-2013January 9, 2013Lake Forest, IL
Abbott Molecular
Class IITerminated
Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; a...
Reason: An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extra...
Z-0634-2013January 9, 2013Des Plaines, IL
Mindray DS USA, Inc. d.b.a. Mindray North America
Class IITerminated
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network ...
Reason: There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
Z-0630-2013January 9, 2013Mahwah, NJ
Hospira Inc.
Class IITerminated
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software ve...
Reason: The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the remov...
Z-0625-2013January 9, 2013Lake Forest, IL
sanofi-aventis US, Inc.
Class IITerminated
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Reason: Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended rest...
Z-0609-2013January 2, 2013Bridgewater, NJ
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed...
Reason: Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address...
Z-0479-2013January 2, 2013Cleveland, OH
Roche Molecular Systems, Inc.
Class IITerminated
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 Sout...
Reason: Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that...
Z-0614-2013January 2, 2013Branchburg, NJ
GE Healthcare, LLC
Class IITerminated
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 Xpr...
Reason: GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mismatch between the label of the tracked vessel and the underlying image associated w...
Z-0560-2013December 26, 2012Waukesha, WI
GE Healthcare, LLC
Class IITerminated
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiolo...
Reason: GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
Z-0524-2013December 26, 2012Waukesha, WI
Roche Molecular Systems, Inc.
Class IITerminated
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 qualita...
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Z-0489-2013December 19, 2012Branchburg, NJ
Roche Molecular Systems, Inc.
Class IITerminated
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLI...
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Z-0484-2013December 19, 2012Branchburg, NJ
Roche Molecular Systems, Inc.
Class IITerminated
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 rang...
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Z-0490-2013December 19, 2012Branchburg, NJ
Roche Molecular Systems, Inc.
Class IITerminated
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 instr...
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Z-0486-2013December 19, 2012Branchburg, NJ
Hospira Inc.
Class IITerminated
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 MedNe...
Reason: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction fo...
Z-0482-2013December 19, 2012Lake Forest, IL
Hospira Inc.
Class IITerminated
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 soft...
Reason: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction fo...
Z-0483-2013December 19, 2012Lake Forest, IL
Roche Molecular Systems, Inc.
Class IITerminated
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.
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Z-0485-2013December 19, 2012Branchburg, NJ
Philips Healthcare Inc.
Class IITerminated
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 trend...
Reason: Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.
Z-0495-2013December 19, 2012Andover, MA
Roche Molecular Systems, Inc.
Class IITerminated
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Z-0491-2013December 19, 2012Branchburg, NJ
Roche Molecular Systems, Inc.
Class IITerminated
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...
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Z-0487-2013December 19, 2012Branchburg, NJ
Roche Molecular Systems, Inc.
Class IITerminated
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.