Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 69 of 120
Philips North America, LLC
Class II Ongoing
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or ...
Z-0853-2019 February 27, 2019 Andover, MA
Baxter Healthcare Corporation
Class II Terminated
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritonea...
Reason: Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Z-0849-2019 February 27, 2019 Deerfield, IL
Philips North America, LLC
Class II Ongoing
PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or ...
Z-0857-2019 February 27, 2019 Andover, MA
Leica Microsystems, Inc.
Class II Terminated
PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for hu...
Reason: The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the pro...
Z-0838-2019 February 27, 2019 Buffalo Grove, IL
Philips North America, LLC
Class II Ongoing
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or ...
Z-0854-2019 February 27, 2019 Andover, MA
Philips North America, LLC
Class II Ongoing
PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or ...
Z-0855-2019 February 27, 2019 Andover, MA
Philips North America, LLC
Class II Ongoing
PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or ...
Z-0856-2019 February 27, 2019 Andover, MA
Philips North America, LLC
Class II Ongoing
PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or ...
Z-0861-2019 February 27, 2019 Andover, MA
Philips Medical Systems (Cleveland) Inc
Class II Terminated
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT su...
Reason: A software update is being issued to correct multiple issues identified in the previous software version.
Z-0823-2019 February 20, 2019 Cleveland, OH
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Reason: The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. ...
Z-0796-2019 February 13, 2019 Mounds View, MN
NEUSOFT MEDICAL SYSTEMS IMP & EX
Class II Terminated
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring...
Reason: For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subse...
Z-0773-2019 February 13, 2019 Shenyang
Becton, Dickinson and Company, BD Biosciences
Class III Terminated
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research f...
Reason: A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows ...
Z-0792-2019 February 13, 2019 San Jose, CA
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro d...
Reason: Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atel...
Z-0782-2019 February 6, 2019 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. ...
Reason: Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atel...
Z-0781-2019 February 6, 2019 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro di...
Reason: Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atel...
Z-0780-2019 February 6, 2019 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in v...
Reason: Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atel...
Z-0783-2019 February 6, 2019 Tarrytown, NY
GE Healthcare, LLC
Class II Terminated
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
Reason: Possible incorrect software version loaded.
Z-0693-2019 January 16, 2019 Waukesha, WI
Agfa-Gevaert, N.V.
Class II Terminated
DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, ...
Reason: After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released....
Z-0692-2019 January 16, 2019 Kontich
Medtronic Navigation, Inc.
Class I Terminated
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version ...
Reason: An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
Z-0552-2019 January 9, 2019 Louisville, CO
Radiometer America Inc
Class II Terminated
ABL800 analyzer, model numbers 393-800 and 393-801.
Reason: The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Z-0682-2019 January 2, 2019 Brea, CA
Medtronic Inc.
Class II Ongoing
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Reason: Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss ...
Z-0683-2019 January 2, 2019 Northridge, CA
Ortho-Clinical Diagnostics
Class II Terminated
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending ...
Reason: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Z-0652-2019 December 26, 2018 Rochester, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to deter...
Reason: Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the...
Z-0616-2019 December 26, 2018 Newark, DE
Ortho-Clinical Diagnostics
Class II Terminated
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the an...
Reason: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Z-0653-2019 December 26, 2018 Rochester, NY
Philips Electronics North America Corporation
Class II Terminated
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
Reason: There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the ...
Z-0614-2019 December 26, 2018 Andover, MA