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.

426–450 of 1375

  • HighFDA (Devices)·Z-2287-2021·2021-08-25

    Trilogy Evo Ventilator Software Defect May Cause Pressure Increase

    Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.

    Product
    Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2165-2021·2021-08-18

    Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch

    Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.

    Product
    Dose IQ Safety Software used with Spectrum IQ Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2074-2021·2021-07-28

    Philips Respironics V60 Plus Ventilator software defect reduces oxygen delivery to patients

    Respironics V60 Plus Ventilators (software versions 3.00 and 3.10) may reduce oxygen flow below clinical settings, risking oxygen desaturation and hypoxemia in mechanically ventilated patients.

    Product
    Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2021·2021-07-21

    MRI Imaging System UI Defect May Cause Incorrect Image Orientation

    GE Healthcare recalled 1,737 SIGNA Creator and SIGNA Explorer MRI systems due to a software bug where the 'Patient Orientation' button can be accidentally clicked instead of 'Save RX,' potentially causing incorrectly oriented diagnostic images.

    Product
    SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1926-2021·2021-06-30

    reSET-O Mobile App Recall: Software Defect Allows Incorrect Reward Access

    Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.

    Product
    reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1925-2021·2021-06-30

    Medical Device Recall: reSET App Grants Rewards Despite Positive Drug Screens

    The reSET Mobile App had a software defect that incorrectly granted patients access to rewards even with positive drug screens. This undermines the clinical logic of substance abuse treatment.

    Product
    reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
    Category
    Medical Device
    Distribution
    16 states
  • HighNHTSA·21V486000·2021-06-29

    Porsche Recalls 2020-2021 Taycan Models for Powertrain Software Fault

    Porsche is recalling certain 2020-2021 Taycan models due to a software monitoring fault that can incorrectly shut down the powertrain, causing loss of motive power and increasing crash risk.

    Product
    PORSCHE — PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V472000·2021-06-24

    2021 Buick Enclave and Chevrolet Traverse Air Bag Software Recall

    General Motors is recalling certain 2021 Buick Enclave and Chevrolet Traverse vehicles due to potentially incorrect air bag calibration software that may affect frontal air bag deployment.

    Product
    CHEVROLET — CHEVROLET, BUICK TRAVERSE, ENCLAVE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2021·2021-06-23

    WorkMate Claris Cardiac Monitoring System Software Error Causes Loss of Functionality

    Abbott's WorkMate Claris cardiac monitoring system may lose functionality or display a black screen during operation due to a software error affecting 4 distributed units.

    Product
    v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2021·2021-06-16

    Medical Device Software Defects in RayStation Treatment Planning System

    RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.

    Product
    RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2021·2021-06-09

    MiniMed 670G Insulin Pump Software Flaw Risks Insulin Overdose

    A software design issue in the MiniMed 670G insulin pump may cause insulin overdose when users are unaware of active insulin levels. Medtronic is recalling clinical study devices.

    Product
    MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1773-2021·2021-06-09

    Change Healthcare Enterprise Viewer software defect affects image display settings

    A software defect in Change Healthcare Enterprise Viewer versions 2.0 and 2.1 prevents the display of image presentation styles. The viewer is used nationwide for displaying medical images.

    Product
    Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V411000·2021-06-02

    Mercedes-Benz and Freightliner Sprinter Recalled for Rearview Camera Software Defect

    Daimler Vans USA is recalling 2019-2021 Mercedes-Benz and Freightliner Sprinter vans because a software defect may cause the rearview camera image to fail to display.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 2500, SPRINTER 1500, SPRINTER 3500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2021·2021-05-26

    RayStation software recall due to incorrect total dose display

    RaySearch Laboratories is recalling RayStation software because the total dose display may be incorrect when using multiple plans in a treatment course.

    Product
    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1597-2021·2021-05-26

    RayStation Software Recall Due to Dose Labeling Error in Merged Beams

    RaySearch Laboratories is recalling RayStation and RayPlan software versions due to a defect that may mislabel approximate radiation doses as clinical doses.

    Product
    RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2021·2021-05-05

    Philips Recalls Xper Flex Cardio Monitors Due to Performance Issues

    Philips is recalling Xper Flex Cardio monitors due to software issues that may cause display delays, freezing, or incorrect data.

    Product
    Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1497-2021·2021-05-05

    Siemens Recalls ARTIS X-Ray Systems Due to Software Issue

    Siemens is recalling 133 ARTIS X-ray systems due to a potential software issue that may require terminating planned procedures.

    Product
    Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2021·2021-04-14

    Medtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation

    Medtronic is recalling A610 Clinician Programmer software versions 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057 due to software errors that prevent proper copying of cycling settings and cause application crashes when reading full system event logs.

    Product
    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1307-2021·2021-03-31

    Biomerieux Recalls VITEK 2 Systems Due to HL7 Software Defect

    Biomerieux is recalling 8,786 VITEK 2 systems worldwide due to a software defect that may cause false susceptible results when using HL7 communication.

    Product
    VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1308-2021·2021-03-31

    Biomerieux Recalls VITEK 2 Compact Systems Due to HL7 Software Defect

    Biomerieux is recalling VITEK 2 Compact systems because a software defect in HL7 communication may prevent expertised interpretation results from being sent to Laboratory Information Systems.

    Product
    VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1202-2021·2021-03-17

    Thermo Fisher Recalls Cascadion Clinical Analyzer Due to Software Defect

    Thermo Fisher Scientific is recalling 19 Cascadion Clinical Analyzers because a software defect may cause false Vitamin D deficiency results.

    Product
    Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·21V181000·2021-03-16

    Peterbilt 536 Recalled for Engine Control Module Software Defect

    PACCAR is recalling one 2021 Peterbilt 536 truck because incorrect engine software may prevent safety features like braking and stability control from functioning properly.

    Product
    PETERBILT — PETERBILT 536
    Category
    Vehicle
    Distribution
    Distributed nationwide