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.

1351–1375 of 1375

  • HighFDA (Devices)·Z-2153-2012·2012-08-15

    Varian ARIA Oncology Software Recall Due to Incorrect MLC Data Import

    Varian Medical Systems is recalling two units of ARIA Oncology Information System software due to a defect that incorrectly imports MLC leaf positions for specific treatment plans.

    Product
    Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2156-2012·2012-08-15

    Philips MultiDiagnost Eleva X-ray System Recalled for 3D Reconstruction Failure

    Philips Healthcare Inc. is recalling 41 units of the MultiDiagnost Eleva X-ray system because the 3D reconstruction feature may fail to start during rotational angiography.

    Product
    Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2107-2012·2012-08-08

    Smiths Medical Medfusion 4000 Syringe Infusion Pump Software Recall

    Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps due to a software anomaly that causes device history log corruption and triggers a Watchdog Fail-Safe alarm.

    Product
    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2068-2012·2012-08-01

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System Software due to a defect that prevents proper quality verification when reagent lots are switched.

    Product
    VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2012·2012-07-25

    Spacelabs Xprezzon Bedside Monitor Recalled for Display Disconnection

    Spacelabs Healthcare is recalling 21 Xprezzon Bedside Monitors because specific key presses can cause patient parameters to disappear from the display.

    Product
    Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1993-2012·2012-07-25

    GE Healthcare Recalls Optima Mobile X-ray Systems Due to Software Issue

    GE Healthcare is recalling Optima XR200 and XR220 mobile X-ray systems because a software issue affects the visual indication required by regulations.

    Product
    GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1985-2012·2012-07-18

    GE OEC InstaTrak 3500 Plus Surgical Navigation System Software Recall

    GE OEC Medical Systems recalled 86 InstaTrak 3500 Plus surgical navigation systems due to software-related issues. The recall was initiated in 2006 but recently classified by the FDA due to administrative delays.

    Product
    InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2012·2012-07-18

    superDimension Systems Software Recall Due to Locatable Guide Malfunction

    superDimension, Inc. is recalling Systems with Software Version 4.0-4.9 because they fail to recognize the Locatable Guide.

    Product
    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1960-2012·2012-07-18

    GE Healthcare Recalls CT/PET Fusion Software Due to Image Alignment Issues

    GE Healthcare is recalling CT/PET Fusion software versions 4.0, 4.1, and 4.2 because fused CT and PET images may be incorrectly aligned.

    Product
    GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2012·2012-07-18

    Philips HeartStart MRx Defibrillator Recalled for ECG Analysis Failure

    Philips is recalling 35 HeartStart MRx defibrillators because they cannot analyze ECG reports during 12-lead acquisition.

    Product
    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2007-2012·2012-07-18

    Elekta Monaco Software Recall for Incorrect Patient Shift Directions

    Elekta, Inc. is recalling Monaco radiation therapy planning software versions 3.10.00 through 3.20.00 due to a defect that prints incorrect patient shift directions when specific DICOM options are enabled.

    Product
    Monaco Product Usage: Planning of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1988-2012·2012-07-18

    Philips Recalls Intellispace Portal Software Due to Missing Warning Messages

    Philips is recalling 96 Intellispace Portal software units to fix a defect where the system fails to display a warning message when launching multiple patient studies.

    Product
    Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2012·2012-07-18

    Philips Medical Systems Recalls IntelliSpace Portal and Extended Brillance Workspace Software

    Philips Medical Systems is recalling 38 units of IntelliSpace Portal and Extended Brillance Workspace software due to inconsistent diagnostic results when using specific time-based methods.

    Product
    IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1791-2012·2012-06-20

    Philips Brilliance iCT and iCT SP CT Systems Software Update Recall

    Philips is issuing a software update for Brilliance iCT and iCT SP systems to address non-conformances that do not result in unacceptable hazards.

    Product
    The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display…
    Category
    Medical Device
    Distribution
    22 states
  • HighNHTSA·11E056000·2011-12-28

    Parker Hannifin Recalls New Flyer Transit Bus Instrument Panels

    Parker Hannifin is recalling instrument panels for New Flyer transit buses due to a software defect that may prevent warning messages from displaying, increasing crash risk.

    Product
    ELECTRICAL SYSTEM: INSTRUMENT CLUSTER/PANEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·11V149000·2011-03-04

    GM Recalls 2011 Buick and Cadillac Vehicles for HVAC Software Defect

    General Motors is recalling 2011 Buick Lacrosse and Cadillac SRX vehicles because a software defect may disable climate control, potentially reducing driver visibility.

    Product
    BUICK — BUICK, CADILLAC LACROSSE, SRX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·10V352000·2010-07-27

    Eldorado Motorhomes Recalled for Defective Wheelchair Lift Software

    Eldorado National is recalling 2008-2010 motorhomes with Ricon wheelchair lifts due to software defects that may cause the platform to overrun the floor level, posing a fall risk.

    Product
    ELDORADO — ELDORADO VERSA SHUTTLE, AERO ELITE, AEROTECH, TRANSTECH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·10V279000·2010-06-21

    Starcraft Allstar Shuttle Buses Recalled for Wheelchair Lift Software Defect

    Starcraft is recalling 2007-2009 Allstar shuttle buses equipped with certain Ricon wheelchair lifts due to a software defect that may cause the lift to overrun the vehicle floor level.

    Product
    STARCRAFT — STARCRAFT ALLSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·10V173000·2010-04-27

    Daimler Recalls 2008-2009 Sprinter Buses with Defective Wheelchair Lifts

    Daimler Buses North America is recalling 2008-2009 Sprinter 3500 buses equipped with certain Ricon wheelchair lifts due to a software defect that may cause the lift to overrun the floor level.

    Product
    SPRINTER BUS — SPRINTER BUS 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·10V120000·2010-03-25

    Goshen Buses Recalled for Wheelchair Lift Software Defect

    Goshen Coach is recalling 2008-2010 buses equipped with certain Ricon wheelchair lifts due to a software defect that may cause the lift to overrun the floor level, posing a fall risk.

    Product
    GOSHEN — GOSHEN PACER II, SENTINEL, PACER LS, GC II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·10V123000·2010-03-25

    Micro Bird School Bus Wheelchair Lift Software Defect Recall

    Micro Bird is recalling 2009-2010 school buses with Ricon wheelchair lifts due to a software defect that may cause the lift to overrun the floor level, posing a fall risk.

    Product
    GIRARDIN — GIRARDIN, MICRO BIRD G5, MB II SCHOOL BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·10V106000·2010-03-17

    Diamond Coach VIP wheelchair lift software defect recall

    NHTSA is recalling 2009 Diamond Coach VIP models with specific wheelchair lifts due to a software defect that may cause the lift to overrun the floor level, posing a fall risk.

    Product
    DIAMOND COACH — DIAMOND COACH VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·10V099000·2010-03-16

    Trans Tech School Buses Recalled for Wheelchair Lift Software Defect

    NHTSA is recalling 2009 Trans Tech school buses equipped with certain Ricon wheelchair lifts due to a software defect that may cause the lift to overrun the floor level.

    Product
    TRANS TECH — TRANS TECH RONDAK DW5138FRL, DW6158FRL, DW8195FRL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·07117·2007-02-28

    Pelagic Recalls Digital Dive Computers Due to Decompression Hazard

    Pelagic Pressure Systems is recalling Oceanic and AERIS digital dive computers because a software defect can cause the display to lock up, potentially leading to decompression sickness.

    Product
    Oceanic and AERIS Digital Dive Computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·01522·2001-08-28

    SoloRider AteeA Model 32 Golf Carts Recalled for Software Defect

    SoloRider Industries is recalling about 200 AteeA Model 32 golf carts because static electricity can corrupt software, causing the cart to move without assistance.

    Product
    SoloRider AteeA Model 32 golf carts
    Category
    Consumer Product
    Distribution
    Distributed nationwide