The Recall Desk

Hazard

Software Defect recalls

1,335 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,335
Critical
14
Severe
91
Most recent
2026-09-09

Of the 1,335 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 91 (7%) 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.

351–375 of 1335

  • HighFDA (Devices)·Z-0849-2022·2022-04-06

    Radiation therapy planning software: incorrect dose density calculation

    RayStation/RayPlan radiation therapy software (versions 4–11A) may incorrectly calculate radiation dose density in treatment planning. The error affects dose calculations in regions partially covered by certain structures.

    Product
    RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2022·2022-03-30

    Azurion Medical Imaging System Software Defect Affects Patient Dose Control

    Philips Azurion R2.1 systems have a software defect that causes the Patient Type to change unexpectedly when starting a procedure, potentially affecting dose control settings without user notification.

    Product
    Azurion systems with software release R2.0.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V168000·2022-03-18

    Mercedes-Benz Recalls Vehicles for Software Configuration Errors

    Mercedes-Benz is recalling specific 2007-2014 models because incorrect software updates may cause loss of drive power or control functions, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ E350, G550, SLK280, CLK550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2022·2022-03-16

    Stryker Camera Control Unit Recalled Due to Inverted Image Display Defect

    Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.

    Product
    1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22E017000·2022-03-10

    Chrysler Recalls Mopar ABS Modules for Electronic Stability Control Defect

    Chrysler is recalling Mopar Anti-lock Brake System (ABS) Control Modules because software may prevent the Electronic Stability Control (ESC) malfunction light from illuminating, increasing crash risk.

    Product
    ELECTRONIC STABILITY CONTROL (ESC) recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V050000·2022-02-02

    Tesla Model Y, S, X, and 3 windshield defrosting software defect

    Tesla is recalling 2020-2022 Model Y, S, X, and 3 vehicles due to a heat pump software error that reduces windshield defrosting performance. This may decrease driver visibility and increase crash risk.

    Product
    TESLA — TESLA MODEL S, MODEL Y, MODEL 3, MODEL X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2022·2022-01-19

    CT Scanner Software Defect May Degrade Image Quality Nationwide

    Siemens SOMATOM Confidence CT scanners with software version VB20_SP5 may experience degraded head image quality, creating a potential risk of misdiagnosis. The recall affects 108 units distributed nationwide.

    Product
    SOMATOM Confidence -Computed tomography systems Model 10590100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2022·2022-01-19

    CT Scanner Software Update Causes Head Image Quality Degradation

    Siemens SOMATOM Definition Edge CT scanners with software version VB20_SP5 may produce degraded head images, increasing the risk of patient misdiagnosis. Devices have been distributed nationwide.

    Product
    SOMATOM Definition Edge -Computed tomography system Model 10590000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2022·2022-01-12

    Clinical Chemistry Analyzer Software Flaw May Cause Inaccurate Test Results

    Siemens is recalling Atellica CH 930 clinical chemistry analyzers with software v1.25.1 or lower. Two software defects could cause inaccurate test results: test parameters may revert to defaults, or the analyzer may use expired reagents.

    Product
    Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2022·2022-01-12

    Alinity m System recalled for software defect in amplification detection

    Abbott Molecular is recalling 742 Alinity m Systems worldwide due to a software defect that can set the Amplification Detection clamp CLEAN position too high, potentially affecting instrument operation.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·21V00J000·2021-12-27

    Mercedes-Benz Recalls 2022 EQS and S-Class for eCall Software Defect

    Mercedes-Benz is recalling 2022 EQS 450, S 500, and S 580 vehicles because a software defect may disable the emergency call system, potentially delaying emergency response.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ S 580, S 500, EQS 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2022·2021-12-08

    Siemens Dimension Vista 500 software issue affects test accuracy

    Siemens is recalling 1,326 Dimension Vista 500 diagnostic devices worldwide due to incorrect default hemolysis, icterus, and lipemia indices that may affect test result accuracy.

    Product
    Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2022·2021-12-01

    Siemens CT Scanner Software May Cause Diagnostic Workflow Delays

    Siemens SOMATOM Definition Edge CT scanners with syngo.CT VB20 software may experience workflow interruptions, causing diagnostic delays, need for repeat scans, and additional contrast media use. 298 units nationwide are affected.

    Product
    SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0271-2022·2021-12-01

    Abbott ARCHITECT Analyzer Software Issues May Cause Inaccurate Test Results

    Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.

    Product
    ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0289-2022·2021-12-01

    CT Scanner Software May Cause Workflow Delays and Patient Rescans

    Siemens SOMATOM Edge Plus CT scanners with syngo.CT VB20 software may experience workflow interruptions, potentially delaying diagnoses and requiring patient rescans. The issue affects 64 units nationwide.

    Product
    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2022·2021-12-01

    CT Scanner Software Issue May Interrupt Diagnostic Workflows and Delay Diagnoses

    Siemens SOMATOM Force CT scanners with software syngo.CT VB20 may experience workflow interruptions, causing diagnosis delays and requiring additional patient scans and contrast media. No illnesses or injuries have been reported.

    Product
    SOMATOM Force with software syngo.CT VB20 Model #10742326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0213-2022·2021-11-17

    Philips Azurion X-Ray Systems may lock up during simultaneous button presses

    Philips Azurion Interventional X-Ray Systems (software 2.1.x) may experience imaging lock-up when operators simultaneously press both the APC and Float Tabletop buttons.

    Product
    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V873000·2021-11-10

    Jeep Wagoneer and Grand Cherokee Airbag Control Software Defect

    The Occupant Restraint Controller software in certain 2021-2022 Jeep models may be faulty, allowing airbags to disable without warning. This increases crash injury risk.

    Product
    JEEP — JEEP WAGONEER, GRAND CHEROKEE, GRAND WAGONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0118-2022·2021-11-03

    Surgical Brain Guidance System Recalled for Inaccurate Electrode Placement

    ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.

    Product
    ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2022·2021-10-20

    Babylog VN500 Ventilator Firmware Defect May Cause Brief Ventilation Interruption

    A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.

    Product
    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2022·2021-10-20

    Evita V500 Ventilator Software Defect May Cause Temporary Ventilation Loss

    Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.

    Product
    Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2021·2021-10-06

    Atomlab 500 Dose Calibrator Software Recall for Incorrect Dose Measurement

    Biodex Medical Systems is recalling Atomlab 500 Dose Calibrator Software versions 2.0.00 through 2.0.08 due to a software defect that can cause incorrect dose measurements and potential misadministration of radioactive material.

    Product
    Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2591-2021·2021-10-06

    MOSAIQ Oncology Information System software defect reverts approved drug strength

    The MOSAIQ Oncology Information System has a software defect where approved changes to drug strength revert to the original value when saved, potentially resulting in incorrect medication dosages.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    17 states