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.

376–400 of 1375

  • 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-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-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-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-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-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-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-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 SIENNA HYBRID, VENZA 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…
    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 X, MODEL 3, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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 C300, C350, E350, G550
    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-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