Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 52 of 120
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implan...
Reason: There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device tri...
Z-1523-2021 May 12, 2021 Mounds View, MN
Datascope Corp.
Class III Ongoing
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998...
Reason: There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical In...
Z-1506-2021 May 5, 2021 Mahwah, NJ
Philips North America Llc
Class II Ongoing
Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service...
Reason: Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; ...
Z-1517-2021 May 5, 2021 Cambridge, MA
CHANGE HEALTHCARE CANADA COMPANY
Class II Ongoing
Change Healthcare Enterprise Viewer
Reason: Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Z-1508-2021 May 5, 2021 Richmond, N/A
Datascope Corp.
Class III Ongoing
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998...
Reason: There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical In...
Z-1507-2021 May 5, 2021 Mahwah, NJ
Siemens Medical Solutions USA, Inc
Class II Terminated
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single a...
Reason: Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
Z-1497-2021 May 5, 2021 Malvern, PA
Welch Allyn Inc Mortara
Class II Terminated
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Reason: Devices do not meet IEC 60601-2-27 requirements as labeled.
Z-1485-2021 April 28, 2021 Milwaukee, WI
Siemens Medical Solutions USA, Inc
Class II Terminated
Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis Hi...
Reason: Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive inform...
Z-1434-2021 April 28, 2021 Malvern, PA
Welch Allyn Inc Mortara
Class II Terminated
Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric po...
Reason: Devices do not meet IEC 60601-2-27 requirements as labeled.
Z-1484-2021 April 28, 2021 Milwaukee, WI
Welch Allyn Inc Mortara
Class II Terminated
ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Reason: Devices do not meet IEC 60601-2-27 requirements as labeled.
Z-1482-2021 April 28, 2021 Milwaukee, WI
Welch Allyn Inc Mortara
Class II Terminated
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Reason: Devices do not meet IEC 60601-2-27 requirements as labeled.
Z-1483-2021 April 28, 2021 Milwaukee, WI
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1397-2021 April 21, 2021 Tarrytown, NY
EOS Imaging
Class II Terminated
The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific...
Reason: Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
Z-1415-2021 April 21, 2021 Paris, N/A
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1396-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1389-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1401-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1399-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1404-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1395-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1394-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1393-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1390-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1405-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1400-2021 April 21, 2021 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Ongoing
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1392-2021 April 21, 2021 Tarrytown, NY