Software recalls
Recalls where the official reason or hazard mentions software. Tags are assigned automatically from the agency text, so always read the official notice.
360 recalls published between October 9, 2024 and September 30, 2026. Most common issues: software (360), injury risk (3), fall (1), crash risk (1). 73 were FDA Class I, the most serious level.
- Automated Impella Controller (AIC) with the below product descriptions and… recall
- Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recall
- SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T… recall
- MR 7700 and Upgrade to MR 7700 recall
- MR 5300 Model Number ( recall
- Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3… recall
- Ingenia Elition S and Ingenia Elition X recall
- Ingenia 3.0T and Ingenia 3.0T CX recall
- Ingenia Ambition S and Ingenia Ambition X recall
- Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S recall
- Evolution upgrade 1.5T and Evolution upgrade 3.0T recall
- Achieva XR recall
- Achieva 3.0T recall
- Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system recall
- VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number:… recall
- DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model recall
- Philips PIC iX Essentials recall
- Philips Patient Information Center iX recall
- StatStrip Glucose and B- Ketone meter recall
- StatStrip Glucose and B- Ketone meter recall
- StatStrip Glucose and B- Ketone meter recall
- StatStrip Glucose Hospital Meter System recall
- StatStrip Glucose Hospital Meter System recall
- Velys Enabling Tech Robotic-Assist Station recall
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System… recall
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System… recall
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System… recall
- Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall
- Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS recall
- FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1… recall
- PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 recall
- PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 recall
- PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 recall
- FUJIFILM Synapse PACS software v7.4.310 recall
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation recall
- Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software… recall
- Beckman Coulter DxC 500i Clinical Analyzer Modules using software version… recall
- Hamilton Microlab STAR Liquid Handler recall
- Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233… recall
- Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068… recall
- GE Healthcare Portrait Core Services SW V 1.2.0 recall
- GE Healthcare MAC VU360 recall
- DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model recall
- munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control… recall
- WASPLab Product Name: WASPLab Model recall
- REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The… recall
- SafeOp Patient Interface recall
- SnapshotGLO Wound Imaging Device, Model KB100, KB100AA recall
- Boston Scientific TheraSphere 360 Y-90 Management Platform… recall
- 3mensio Workstation (Vascular Fenestrated) software recall
- The intended use is to be paired with a weapon for aiming purposes recall
- MiniMed 780G Insulin Pump recall
- Thuvera Laser Console recall
- STAAR ICL Calculation Software Software Version: Version 8.00 Product… recall
- Automated Impella Controller (AIC), for use with left heart support blood… recall
- MOSAIQ Oncology Information System recall
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer… recall
- MAC 5 A4 Resting ECG Analysis System 855001-001 recall
- LVP software of the Ivenix Infusion System (IIS) recall
- Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer… recall