Hazard Type

Software Defect Recalls

1,491 product recalls involving software defect. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

1,491Total Recalls
113Critical
36.5MUnits Affected
All Recalls

Every Software Defect Recall

Sorted by most recent. Click any recall for full details and safety information.

1,491 recalls
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost R90 Software Version R1.0 and R1.1
Diagnostic Devices·322 affected·Jul 22, 2020
High RiskFDA
Medtronic Neuromodulation
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Medical Devices·2,408 affected·Jul 17, 2020
High RiskFDA
Sicat Gmbh & Co. Kg
SICAT IMPLANT V2.0
Medical Implants·853 affected·Jul 15, 2020
High RiskFDA
Neurologica Corporation
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is inte...
Medical Devices·35 affected·Jul 15, 2020
High RiskFDA
Medtronic Inc.
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Medical Devices·3,588 affected·Jul 15, 2020
CriticalFDA
Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software
Medical Devices·146,224 affected·Jun 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Medical Devices·60 affected·Jun 2, 2020
High RiskFDA
Radiometer Medical Aps
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available i...
Medical Devices·4,615 affected·May 26, 2020
High RiskFDA
Radiometer Medical Aps
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available a...
Medical Devices·3,899 affected·May 26, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1,...
Medical Devices·12 affected·May 26, 2020
High RiskFDA
Vitalconnect Inc.
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display phys...
Medical Devices·7 affected·May 21, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Diagnostic Devices·779 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Medical Devices·130 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Medical Devices·353 affected·May 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to ...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to a...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to a...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tre...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tre...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer trea...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Merge Healthcare, Inc.
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage...
Medical Devices·62 affected·May 8, 2020
High RiskFDA
The Binding Site Group, Ltd.
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry A...
Diagnostic Devices·36 affected·Apr 9, 2020
High RiskFDA
Inpeco S.a.
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N...
Medical Devices·3 affected·Apr 7, 2020
High RiskFDA
Inpeco S.a.
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-0...
Medical Devices·37 affected·Apr 7, 2020
High RiskFDA
Philips North America, Llc
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Intervent...
Medical Devices·22 affected·Apr 3, 2020
RecallFDA
Immersivetouch Inc
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating s...
Surgical Devices·2 affected·Apr 3, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is in...
Medical Devices·3 affected·Mar 26, 2020
High RiskFDA
Sysmex America, Inc.
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, sele...
Medical Devices·93 affected·Mar 9, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product U...
Medical Devices·1,389 affected·Mar 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Medical Devices·1,807 affected·Feb 27, 2020
High RiskFDA
Synaptive Medical Inc
ClearCanvas RIS/PACS
Medical Devices·903 affected·Feb 26, 2020
High RiskFDA
Butterfly Network, Inc.
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-2...
Diagnostic Devices·15,121 affected·Feb 24, 2020
High RiskFDA
Butterfly Network, Inc.
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software ve...
Diagnostic Devices·11,183 affected·Feb 24, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Philips North America, Llc
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.0...
Medical Devices·2,214 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Medical Devices·1 affected·Feb 20, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 ...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Syst...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Icu Medical, Inc.
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619...
Cardiac Devices·123 affected·Feb 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: A...
Diagnostic Devices·1,452 affected·Feb 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 1...
Diagnostic Devices·1,452 affected·Feb 14, 2020
High RiskFDA
Boston Scientific Corporation
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended ...
Medical Implants·4 affected·Feb 12, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Medical Devices·870,070 affected·Feb 4, 2020