The Recall Desk

Hazard

Software Anomaly recalls

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

What the numbers show

Total
118
Critical
4
Severe
10
Most recent
2026-07-15

Of the 118 software anomaly recalls we have scored against our rubric, 4 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (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 anomaly 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.

76–100 of 118

  • HighFDA (Devices)·Z-1813-2018·2018-05-23

    Draeger Infinity Acute Care System Recalled for Software Anomaly

    Draeger Medical Systems is recalling the Infinity Acute Care System due to a software anomaly that can cause loss of patient settings and stored data.

    Product
    Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1585-2018·2018-05-09

    Hitachi MHI-TM2000 Linear Accelerator Recalled for Software Anomaly

    Hitachi is recalling one MHI-TM2000 Linear Accelerator System in New York due to a software anomaly that may prevent patient positioning correction, potentially irradiating the wrong body part.

    Product
    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0254-2018·2017-12-20

    Ortho-Clinical enGen Track System Software Recall for Result Delays

    Ortho-Clinical Diagnostics is recalling 16 enGen Track Systems with TCAutomation Software Version 4.2 due to a software anomaly that may delay result reporting.

    Product
    enGen Track System with TCAutomation Software Version 4.2
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2864-2017·2017-08-09

    Hologic Tomcat Instrument Recalled for Software Anomaly Affecting Sample Processing

    Hologic is recalling 164 Tomcat Instruments due to a software anomaly that may cause the pipettor arm to contact the mucous shelf, potentially leading to incorrect patient results.

    Product
    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2017·2017-05-24

    Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems due to a software anomaly that may cause sample ID misassociation, potentially leading to misdiagnosis.

    Product
    enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-2075-2017·2017-05-24

    Zimmer CAS Recalls Navitrack System Knee Instrument Due to Software Anomalies

    Zimmer CAS is voluntarily recalling 152 units of the Navitrack System - OS Knee Universal due to software anomalies corrected in a new revision.

    Product
    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1890-2017·2017-05-10

    Medtronic Recalls MiniMed 620G and 640G Insulin Pumps Due to Software Anomaly

    Medtronic is recalling MiniMed 620G and 640G insulin pumps with software version 2.6 or below because a software anomaly can prevent the internal battery from charging, leading to pump shutdown.

    Product
    MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1693-2017·2017-04-05

    Baxter SIGMA Spectrum Infusion Pump Software Anomaly Recall

    Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library due to a software anomaly that may cause a Sharp Watchdog Timeout error.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0721-2017·2016-12-14

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software versions 4.0, 4.5, 4.7, and 5.0 due to potential inaccuracies in proton dose calculations for specific treatment plans.

    Product
    RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2879-2016·2016-10-05

    CareFusion Recalls Alaris Syringe Modules Due to Software Anomaly

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units with software version 9.15 because a software anomaly may cause infusions to stop unexpectedly.

    Product
    Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2405-2016·2016-08-17

    Topcon Recalls PASCAL Synthesis Ophthalmic Laser Systems Due to Titration Anomaly

    Topcon Medical Laser Systems is recalling 205 PASCAL Synthesis ophthalmic laser systems worldwide due to a software anomaly affecting the titration process when specific functions are used.

    Product
    Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1244-2016·2016-03-30

    MHI-TM2000 Linear Accelerator Software Recall for Treatment Status Error

    Mitsubishi Heavy Industries is recalling MHI-TM2000 Linear Accelerator Systems due to a software anomaly that may incorrectly change a patient's treatment status to 'Untreated'.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0641-2016·2016-01-20

    Ortho-Clinical VITROS 5600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may cause erroneous test results without user notification.

    Product
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2016·2016-01-20

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0642-2016·2016-01-20

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2016·2016-01-20

    Ortho-Clinical VITROS 3600 Chemistry System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Chemistry Systems due to a software anomaly that may allow the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2015·2015-06-17

    Ortho-Clinical VITROS 5600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.

    Product
    VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2015·2015-06-03

    OptiMedica Catalys Precision Laser System Software Recall for Incorrect Parameters

    OptiMedica is recalling Catalys Precision Laser Systems with software version 3.00.05 because a software anomaly may provide incorrect cataract surgery parameters.

    Product
    Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1521-2015·2015-05-06

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems with software version 2.8 or below due to a potential anomaly that may cause the device to process samples with the wrong cartridge, leading to erroneous patient results.

    Product
    Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vi
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1070-2015·2015-02-18

    TeraRecon Recalls Aquarius iNtuition Client Viewer Software Due to Anomaly

    TeraRecon is recalling 91 units of the Aquarius iNtuition Client Viewer due to a software anomaly in the RECIST 1.1 evaluation criteria.

    Product
    Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and vi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0967-2015·2015-01-21

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2015·2015-01-21

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because software versions 3.1 and below may fail to identify expired calibrations.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using bot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0969-2015·2015-01-21

    Ortho VITROS 5600 System Recalled for Software Calibration Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because software may fail to identify expired calibrations.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2015·2014-12-31

    Bausch & Lomb Stellaris PC Laser Recall for Software Anomaly

    Bausch & Lomb is recalling 106 Stellaris PC laser systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.

    Product
    Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0863-2015·2014-12-31

    Bausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly

    Bausch & Lomb is recalling 79 Stellaris PC Vision Enhancement Systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.

    Product
    Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and cert
    Category
    Medical Device
    Distribution
    21 states