Software recalls – page 3

• Surgical Planner, BrainSTORM, software version BST.9.3.0… recall
  FDA November 5, 2025 · Surgical Theater Inc · Class II
• SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR… recall
  FDA November 5, 2025 · Surgical Theater Inc · Class II
• Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP)… recall
  FDA November 5, 2025 · Surgical Theater Inc · Class II
• SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR… recall
  FDA November 5, 2025 · Surgical Theater Inc · Class II
• Surgical Navigation Advanced Platform Patient Engagement (PE SNAP)… recall
  FDA November 5, 2025 · Surgical Theater Inc · Class II
• Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0… recall
  FDA November 5, 2025 · Surgical Theater Inc · Class II
• SuRgical Planner (SRP), software version SRP.7.12.0… recall
  FDA November 5, 2025 · Surgical Theater Inc · Class II
• Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and… recall
  FDA November 5, 2025 · Dexcom, Inc. · Class I
• t:slim X2 insulin pump with Interoperable Technology… recall
  FDA October 29, 2025 · Tandem Diabetes Care, Inc. · Class II
• DxI 9000 Access Immunoassay Analyzer, Part Number C11137 recall
  FDA October 29, 2025 · Beckman Coulter, Inc. · Class II
• DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE… recall
  FDA October 29, 2025 · Beckman Coulter, Inc. · Class II
• GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with… recall
  FDA October 29, 2025 · Wipro GE Healthcare Private Ltd. · Class II
• GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with… recall
  FDA October 29, 2025 · Wipro GE Healthcare Private Ltd. · Class II
• ARVIS Product Name: ARVIS" Shoulder Model recall
  FDA October 22, 2025 · Kico Knee Innovation Company · Class II
• Model Number U228, VISIONIST CRT-P EL MRI recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number U226, VISIONIST CRT-P EL recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number U225 VISIONIST CRT-P EL recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number U128, VALITUDE CRT-P EL MRI recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number U125, VALITUDE CRT-P EL recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number S722, ALTRUA 2 DR EL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number S702, ALTRUA 2 DR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number S701 ALTRUA 2 SR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L131, ESSENTIO DR EL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L121 ESSENTIO DR EL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L111, ESSENTIO DR SL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L110, ESSENTIO SR SL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L101, ESSENTIO DR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L100, ESSENTIO SR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L231, PROPONENT DR EL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L221 PROPONENT DR EL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L211 PROPONENT DR SL MRI Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L210 PROPONENT SR SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• Model Number L209 PROPONENT DR (VDD) SL Pacemaker recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• PROPONENT DR SL (Model L201) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• PROPONENT SR SL (Model L200) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR EL MRI (Model L331) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR EL (Model L321) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR SL MRI (Model L311) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE SR SL MRI (Model L310) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR SL (Model L301) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE SR SL (Model L300) recall
  FDA October 22, 2025 · Boston Scientific Corporation · Class I
• This device is a digital radiography/fluoroscopy system used in a… recall
  FDA October 15, 2025 · Canon Medical System, USA, INC. · Class II
• ZAP-X Radiosurgery System, Model: 300150 recall
  FDA October 8, 2025 · Zap Surgical Systems · Class II
• Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to… recall
  FDA October 8, 2025 · Bard Peripheral Vascular Inc · Class II
• Change Healthcare Radiology Solutions software version 14.2.2 recall
  FDA October 8, 2025 · Change Healthcare Canada Company · Class II
• Pinnacle Radiation Therapy Planning System: Multimodality Simulation… recall
  FDA September 24, 2025 · Philips Medical Systems (Cleveland) Inc · Class II
• IntelliSpace Cardiovascular, Software 8.0.0.4 recall
  FDA September 17, 2025 · Philips Medical Systems Nederland B.V. · Class II
• InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) recall
  FDA September 10, 2025 · Medtronic MiniMed, Inc. · Class II
• RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X1100… recall
  FDA September 10, 2025 · Reflexion Medical, Inc. · Class II
• IDM-ARLITE-R. Electrical wheelchair component recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• All-round Joystick R-net Light recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• IDM-MULTI-R. Electrical wheelchair component recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• IDM-MICRO-R. Electrical wheelchair component recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• Multi Joystick R-net recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• Micro Joystick R-net recall
  FDA September 10, 2025 · mo-Vis BVBA · Class I
• Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA September 10, 2025 · Dexcom, Inc. · Class I