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.

326–350 of 1335

  • HighFDA (Devices)·Z-1426-2022·2022-07-27

    Sensis Vibe Combo Device Recalled for Software Communication Failure

    The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.

    Product
    Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V508000·2022-07-15

    Isuzu Recalls 2022 FTR and FVR Trucks Due to Engine Braking Defect

    Isuzu is recalling 2022 FTR and FVR trucks because a software error disables engine braking, potentially increasing stopping distances and crash risk.

    Product
    ISUZU — ISUZU FTR, FVR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2022·2022-06-22

    Medtronic Cobalt ICD and CRT-D Telemetry Software Error Recall

    Medtronic is recalling Cobalt and Crome ICDs and CRT-Ds due to a software telemetry error in the CareLink SmartSync Device Manager. The error may affect device communication and remote monitoring.

    Product
    Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2022·2022-06-15

    Medical imaging software measurement accuracy error in Centricity PACS RA1000

    GE Healthcare's Centricity PACS RA1000 medical imaging software may display inaccurate distance and area measurements on magnified or scaled images, potentially affecting diagnostic accuracy.

    Product
    Centricity PACS RA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2022·2022-06-15

    Medical imaging software may display inaccurate measurement values

    GE Healthcare's Centricity Universal Viewer Zero Footprint Client may display inaccurate distance and area measurements on magnified or scaled images.

    Product
    Centricity Universal Viewer Zero Footprint Client
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2022·2022-06-08

    Bio-Rad Sickle Cell Testing Software CD-ROM Defect Overwrites Custom Settings

    Bio-Rad is recalling Resin Update CD-ROM software (Model 250-3020) for the VARIANT nbs Sickle Cell Program because the update procedure overwrites custom laboratory settings, potentially causing incorrect pattern assignment in tested samples.

    Product
    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
    Category
    Medical Device
    Distribution
    24 states
  • HighNHTSA·22V382000·2022-05-27

    Ford Recalls 2019-2020 Mustangs for Software Defect Affecting Safety Features

    Ford is recalling 25,032 2019-2020 Mustangs with 5.0L engines and manual transmissions because a software defect may disable the reverse camera, reverse light, and driver assist features, increasing crash risk.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V360000·2022-05-20

    Daimler Recalls 2019-2021 Sprinter Vehicles for eCall Software Defect

    Daimler Vans USA is recalling 2019-2021 Freightliner and Mercedes-Benz Sprinter vehicles because a software error may disable the emergency call system.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 4500, SPRINTER 2500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2022·2022-05-18

    Phototherapy Units Recalled for Software Bug Causing Incorrect Dosing

    Daavlin's 4 Series CX phototherapy units are recalled due to a software defect that can cause incorrect dosing (over or under) when resuming interrupted treatments.

    Product
    4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2022·2022-05-18

    VITEK 2 Systems Software Issue May Produce Incorrect Antibiotic Test Results

    bioMerieux VITEK 2 bacterial identification systems have a software defect where antibiotic susceptibility and synergy test results transmitted to laboratory systems may omit user or automated corrections, potentially leading to incorrect test interpretation.

    Product
    VITEK 2 Systems and VITEK 2 with MYLA.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1073-2022·2022-05-18

    Daavlin 1 Series CX Phototherapy Units Recalled for Software Dosing Error

    Daavlin is recalling 1 Series CX phototherapy units due to a software bug that swaps calibration distance settings when resuming interrupted treatments, resulting in incorrect dosing.

    Product
    1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2022·2022-05-11

    Robotic-Assisted Medical Device Recalled Due to Software Defect

    The FDA is recalling the VELYS Robotic-Assisted Solution Base due to a software defect in version 1.5.1 related to Daylight Saving Time changes. The defect can cause system errors requiring restart, potentially delaying patient treatment.

    Product
    VELYS Robotic-Assisted Solution Base Product No.: 451570100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2022·2022-05-11

    Medical Device Software Update Overwrites Custom Antibiotic Codes

    BD Synapsys Microbiology Informatics Software version 4.10 overwrites customer-configured antibiotic codes with BD defaults during system updates, affecting data integrity in clinical microbiology reporting.

    Product
    BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2022·2022-05-11

    Azurion Medical Imaging System Software Defect Alters Dose Parameters

    A software defect in Philips Azurion imaging systems causes the Patient Type to change unexpectedly during study initiation, altering dose control parameters without operator notification.

    Product
    Azurion systems with software release R1.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2022·2022-05-04

    CT scanner software upgrade causes incorrect laser position display

    Siemens CT scanner software upgrade may display incorrect laser offset coordinates during patient marking. This defect affects 15 systems in the US across multiple states.

    Product
    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0992-2022·2022-05-04

    PrisMax System software causes unalerted treatment parameter reversion

    The PrisMax System may revert custom treatment parameters to default values without notifying the operator when the Same Patient function is used. This could cause patients to receive unintended treatment settings.

    Product
    PrisMax System, Product Code 955724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2022·2022-05-04

    PrisMax System software anomaly affects therapy parameter settings

    The PrisMax System has a software defect that can silently revert custom therapy parameters to defaults when using the Same Patient function without notifying the operator.

    Product
    PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2022·2022-04-27

    Diagnostic imaging system software malfunction may interrupt clinical procedures

    Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.

    Product
    Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0957-2022·2022-04-27

    Abbott TactiCath Ablation Catheters Recalled for Software-Disabled Devices

    Abbott has recalled 588 TactiCath ablation catheters that were preprogrammed with a 'First Use Date' disabling device functionality. The catheters were distributed worldwide and throughout the U.S.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2022·2022-04-20

    MUSE Cardiology System edits and diagnosis data lost after test signed

    GE Healthcare's MUSE Cardiology Information System may lose test measurement edits and diagnosis statements after signing. The Class II recall affects 147 units in the US and internationally.

    Product
    MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V240000·2022-04-13

    2022-2023 BMW iX Air Bag Warning System Software Defect

    BMW is recalling 2022-2023 iX vehicles due to incorrect software in the air bag control unit. The malfunction indicator light may not illuminate if the air bag system has a problem, increasing crash injury risk.

    Product
    BMW — BMW IX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V239000·2022-04-13

    Electronic Stability Control Software Defect in 2022 Toyota RAV4 Prime and Other Models

    Certain Toyota and Lexus vehicles may have a software defect preventing the Electronic Stability Control system from re-engaging after being manually disabled. Dealers will update the software free of charge.

    Product
    TOYOTA — TOYOTA, LEXUS VENZA HYBRID, SIENNA HYBRID, MIRAI, redundant VENZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2022·2022-04-13

    Philips Allura and Azurion X-ray systems may display incorrect previous images

    Philips Allura and Azurion X-ray systems running StentBoost Live R2.0 may display images from previous scans or other patients due to a software defect. 338 units are affected and globally distributed.

    Product
    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V235000·2022-04-12

    Tesla Model S Boombox function obscures pedestrian warning system sounds

    Tesla is recalling certain 2020-2022 Model S, X, Y and 2017-2022 Model 3 vehicles. The Boombox feature can obscure Pedestrian Warning System sounds while driving. A free software update will disable Boombox in Drive, Neutral, and Reverse modes.

    Product
    TESLA — TESLA MODEL 3, MODEL X, MODEL Y, MODEL S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2022·2022-04-06

    Radiation therapy planning software subject to jaw positioning errors during optimization

    RayStation radiation therapy planning software (versions 6-11A) may unexpectedly change jaw positions during optimization after dose or target modifications. Users should verify treatment plans carefully before delivery.

    Product
    TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 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, 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, 10.1.0.613, 11.0.0.951 or 11.0.1.2
    Category
    Medical Device
    Distribution
    Distributed nationwide