The Recall Desk

Hazard

Software Defect recalls

1,375 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,375
Critical
14
Severe
106
Most recent
2026-10-21

Of the 1,375 software defect recalls we have scored against our rubric, 14 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 106 (8%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 1375

  • ModerateFDA (Devices)·Z-3317-2026·2026-10-07

    Philips MR 7700 Software Upgrade Recalled for Incorrect DTI Data

    Philips is recalling 30 MR 7700 software upgrades because they export incorrect diffusion tensor imaging data, preventing accurate nerve fiber mapping.

    Product
    Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3251-2026·2026-09-30

    Abiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects

    Abiomed is recalling 3,322 Automated Impella Controllers worldwide due to firmware and software defects that affect pressure signal accuracy and system reliability.

    Product
    Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3232-2026·2026-09-30

    Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue

    Philips is recalling 387 Achieva 1.5T MRI systems worldwide because a software issue may terminate examinations if manual scan adjustments exceed system memory.

    Product
    Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3241-2026·2026-09-30

    Philips MR 5300 MRI Scanner Software Recall for Image Reconstruction Failure

    Philips is recalling 611 MR 5300 MRI scanners due to a software issue that can terminate examinations during image reconstruction if system memory is exceeded.

    Product
    MR 5300 Model Number (REF): 1. 782110, 2. 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3238-2026·2026-09-30

    Philips Ingenia MRI Software Recall for Memory-Related Scan Termination

    Philips is recalling Ingenia 3.0T and 3.0T CX MRI systems because a software issue can terminate examinations during image reconstruction if scan parameters exceed available system memory.

    Product
    Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3237-2026·2026-09-30

    Philips Ingenia Ambition MRI Software Recall for Memory Limit Issue

    Philips is recalling 922 Ingenia Ambition MRI systems due to a software issue that can terminate examinations if system memory is exceeded.

    Product
    Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3242-2026·2026-09-30

    Philips MR 7700 MRI Systems Recalled for Software Issue

    Philips is recalling 37 MR 7700 MRI systems due to a software issue that can terminate examinations during image reconstruction.

    Product
    MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3233-2026·2026-09-30

    Philips Achieva 3.0T MRI Software Recall for Memory Limit Issues

    Philips is recalling 210 Achieva 3.0T MRI scanners because a software issue can terminate examinations if system memory is exceeded during image reconstruction.

    Product
    Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3240-2026·2026-09-30

    Philips Intera 1.5T MRI Systems Recalled for Software Issue

    Philips is recalling 82 Intera 1.5T MRI systems worldwide because a software issue can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.

    Product
    Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3236-2026·2026-09-30

    Philips Ingenia MRI Software Recall for Image Reconstruction Failure

    Philips is recalling 2,038 Ingenia 1.5T MRI systems worldwide due to a software issue that can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.

    Product
    Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3234-2026·2026-09-30

    Philips Achieva XR MRI Systems Recalled for Software Memory Issue

    Philips is recalling 15 Achieva XR MRI systems because a software issue can terminate examinations if scan parameters exceed system memory.

    Product
    Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3239-2026·2026-09-30

    Philips Ingenia MRI Software Recall for Image Reconstruction Failure

    Philips is recalling 596 Ingenia Elition MRI systems due to a software issue that can terminate examinations during image reconstruction if system memory is exceeded.

    Product
    Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3174-2026·2026-09-23

    PTW Freiburg Recalls VERIQA RT MonteCarlo 3D Software Due to Bolus Display Error

    PTW Freiburg is recalling VERIQA RT MonteCarlo 3D software because it fails to clearly display bolus inclusion during secondary dose calculation, which may lead to incorrect dose delivery.

    Product
    Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3129-2026·2026-09-23

    Nova Biomedical StatStrip Glucose Hospital Meter System Recalled for Software Defect

    Nova Biomedical is recalling StatStrip Glucose Hospital Meter Systems due to a software defect that can cause patient glucose results to be assigned to the wrong medical record.

    Product
    StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3164-2026·2026-09-23

    Nuclein DASH Rapid PCR Instrument Recalled for Software Issue

    Nuclein LLC is recalling 182 DASH Rapid PCR Instruments due to a software issue. The recall affects units distributed in 18 US states.

    Product
    Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3066-2026·2026-09-09

    Baxter Novum IQ Syringe Pump Recalled for Software Infusion Issue

    Baxter Healthcare is recalling four Novum IQ Syringe Pump loaner units due to a software issue that may occur during multi-syringe infusions.

    Product
    Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3065-2026·2026-09-09

    Baxter Novum IQ Syringe Pump Software Issue Recall

    Baxter Healthcare is recalling 14,601 Novum IQ Syringe Pumps due to a software issue that may occur during multi-syringe infusions.

    Product
    Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3088-2026·2026-09-09

    Medos Velys Robotic-Assist Station Recalled for Software Movement Issue

    Medos International Sarl is recalling 29 Velys Robotic-Assist Stations due to a software issue that may cause unintended robotic arm movement during surgery.

    Product
    Velys Enabling Tech Robotic-Assist Station REF: 451611001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3013-2026·2026-09-02

    Midmark Digital ECG Software Recall for Incorrect Waveform Display

    Midmark is recalling Digital ECG HD+12 and HD+15 units with specific IQecg plugin software versions due to a communication anomaly that may cause incorrect ECG waveforms and inaccurate heart rate calculations.

    Product
    Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3012-2026·2026-09-02

    Midmark IQecg Digital ECG Software Recall for Inaccurate Waveforms

    Midmark is recalling IQecg Digital ECG software due to a communication anomaly that may cause incorrect waveforms and inaccurate heart rate calculations.

    Product
    Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2973-2026·2026-08-26

    Beckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect

    Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.

    Product
    Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2950-2026·2026-08-26

    EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags

    FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.

    Product
    EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V549000·2026-08-25

    Mitsubishi Recalls Outlander Models for Rearview Camera Software Defect

    Mitsubishi is recalling 2025-2026 Outlander and 2026 Outlander PHEV vehicles because a software error may prevent the rearview camera image from displaying, increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26E059000·2026-08-19

    Avride Recalls Automated Driving Systems Due to Unsafe Lane Changes

    Avride Inc. is recalling Automated Driving Systems (ADS) with specific software versions that may cause unsafe lane changes or merging without yielding.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2932-2026·2026-08-19

    Philips Azurion Fluoroscopy System Recall for Software Image Quality Issues

    Philips is recalling 2,016 Azurion interventional fluoroscopic x-ray systems worldwide due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.

    Product
    Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states