Software recalls – page 4

• Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump recall
  FDA September 10, 2025 · Baxter Healthcare Corporation · Class I
• Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump recall
  FDA September 10, 2025 · Baxter Healthcare Corporation · Class I
• Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump recall
  FDA September 10, 2025 · Baxter Healthcare Corporation · Class I
• BD Pyxis Product Name / UDI-DI code recall
  FDA September 3, 2025 · CareFusion 303, Inc. · Class II
• 3mensio Workstation (Vascular Fenestrated) software recall
  FDA August 20, 2025 · PIE Medical Imaging B.V. · Class II
• DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 recall
  FDA August 13, 2025 · Beckman Coulter, Inc. · Class II
• DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 recall
  FDA August 13, 2025 · Beckman Coulter, Inc. · Class II
• UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 recall
  FDA August 13, 2025 · Beckman Coulter, Inc. · Class II
• DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 recall
  FDA August 13, 2025 · Beckman Coulter, Inc. · Class II
• DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 recall
  FDA August 13, 2025 · Beckman Coulter, Inc. · Class II
• UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 recall
  FDA August 13, 2025 · Beckman Coulter, Inc. · Class II
• Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System… recall
  FDA August 13, 2025 · Philips Medical Systems (Cleveland) Inc · Class II
• ASPRIRE Cristalle Mammography System (cleared under K212873) installed… recall
  FDA August 6, 2025 · FUJIFILM Healthcare Americas Corporation · Class II
• Philips Allura R8.2.x Systems recall
  FDA August 6, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Inseego USB8 4G Dongle Kit, Part Number: 01-2298… recall
  FDA August 6, 2025 · Remote Diagnostic Technologies Ltd. · Class II
• Medtronic SmartLink software loaded on CareLink SmartSync Device Manager… recall
  FDA July 23, 2025 · Medtronic, Inc. · Class II
• Medtronic SmartLink Software loaded on SmartSync Patient Connector… recall
  FDA July 23, 2025 · Medtronic, Inc. · Class II
• Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 recall
  FDA July 23, 2025 · Baxter Healthcare Corporation · Class I
• Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX recall
  FDA July 23, 2025 · Baxter Healthcare Corporation · Class I
• Varicam, Millennium VG, Millennium VG Hawkeye… recall
  FDA July 16, 2025 · Ge Medical Systems Israel, Functional Imaging · Class II
• Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear… recall
  FDA July 16, 2025 · Ge Medical Systems Israel, Functional Imaging · Class II
• Change Healthcare Cardiology Hemodynamics Software recall
  FDA July 9, 2025 · Change Healthcare Canada Company · Class II
• Change Healthcare Cardiology Hemo Software recall
  FDA July 9, 2025 · Change Healthcare Canada Company · Class II
• VITROS Product Name: VITROS 4600 Chemistry System Model recall
  FDA July 9, 2025 · Ortho-Clinical Diagnostics, Inc. · Class II
• VITROS; Product Name: VITROS XT 7600 Integrated System… recall
  FDA July 9, 2025 · Ortho-Clinical Diagnostics, Inc. · Class II
• VITROS Product Name: VITROS 5600 Integrated System Model recall
  FDA July 9, 2025 · Ortho-Clinical Diagnostics, Inc. · Class II
• interventional fluoroscopic x-ray system recall
  FDA July 9, 2025 · Siemens Medical Solutions USA, Inc · Class II
• interventional fluoroscopic x-ray system recall
  FDA July 9, 2025 · Siemens Medical Solutions USA, Inc · Class II
• interventional fluoroscopic x-ray system recall
  FDA July 9, 2025 · Siemens Medical Solutions USA, Inc · Class II
• ARTIS is a family of dedicated angiography systems developed for single… recall
  FDA July 9, 2025 · Siemens Medical Solutions USA, Inc · Class II
• Spectral CT. Computed tomography X-ray system recall
  FDA July 2, 2025 · Philips North America Llc · Class II
• REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487 recall
  FDA July 2, 2025 · Beckman Coulter, Inc. · Class II
• Product Name [ recall
  FDA July 2, 2025 · CareFusion 303, Inc. · Class II
• Omnipod 5 Automated Insulin Delivery System, iOS Application recall
  FDA July 2, 2025 · Insulet Corporation · Class II
• Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1… recall
  FDA July 2, 2025 · Bigfoot Biomedical · Class II
• ICU Medical Plum Solos, Item number 400011001 recall
  FDA June 25, 2025 · ICU Medical, Inc. · Class II
• ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001… recall
  FDA June 25, 2025 · ICU Medical, Inc. · Class II
• Azurion R1.x and R2.x systems recall
  FDA June 18, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Guardian 2 System Product Name: Guardian System 2 Controller Model recall
  FDA June 18, 2025 · Turncare, Inc · Class II
• Guardian 2 System Product Name: Guardian System 2 Controller Model recall
  FDA June 18, 2025 · Turncare, Inc · Class II
• iBOT PMD with software version 01.05.24. Personal Mobility Device recall
  FDA June 18, 2025 · Mobius Mobility LLC · Class II
• EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a… recall
  FDA June 18, 2025 · Quantum Surgical Sas · Class II
• Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with… recall
  FDA June 18, 2025 · Cardinal Health 200, LLC · Class II
• Kendall SCD Comfort Sleeves Knee Length Small… recall
  FDA June 18, 2025 · Cardinal Health 200, LLC · Class II
• SCD Comfort Knee Length Small, SKU 84021 recall
  FDA June 18, 2025 · Cardinal Health 200, LLC · Class II
• Z-800WF Infusion System recall
  FDA June 18, 2025 · Zyno Medical LLC · Class I
• Z-800W Infusion System recall
  FDA June 18, 2025 · Zyno Medical LLC · Class I
• Z-800F Infusion System recall
  FDA June 18, 2025 · Zyno Medical LLC · Class I
• Z-800 Infusion System recall
  FDA June 18, 2025 · Zyno Medical LLC · Class I
• DxI 9000 Access Immunoassay Analyzer recall
  FDA June 11, 2025 · Beckman Coulter, Inc. · Class II
• MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical… recall
  FDA June 11, 2025 · Virtual Incision Corporation · Class II
• Catalyst+ Product Name: C4D software used in conjunction with Catalyst… recall
  FDA June 4, 2025 · C-Rad Positioning Ab · Class II
• PhenoMATRIX recall
  FDA May 28, 2025 · Copan WASP · Class II
• True 3D Viewer, Model: EP-00003 recall
  FDA May 28, 2025 · Echopixel, Inc. · Class II
• DxC 500 AU Clinical Chemistry Analyzer recall
  FDA May 21, 2025 · Beckman Coulter, Inc. · Class II
• LifeShield Drug Library Management (DLM), LifeShield Infusion Safety… recall
  FDA May 21, 2025 · ICU Medical, Inc. · Class II
• IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x recall
  FDA May 14, 2025 · Philips Medical Systems Nederland B.V. · Class II
• Blueprint Software, BPUE001. Intended for use by surgeons as a pre… recall
  FDA May 14, 2025 · Tornier S.A.S. · Class II
• Philips Tempus Pro Patient Monitor recall
  FDA May 14, 2025 · Remote Diagnostic Technologies Ltd. · Class II
• Quantum Informatics - VISION / LIVE VUE Product Name: Monitor… recall
  FDA May 7, 2025 · Spectrum Medical Ltd. · Class II