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.

751–775 of 1335

  • ModerateFDA (Devices)·Z-3075-2017·2017-09-06

    BioMérieux Recalls VITEK 2 Compact 15 Software and Reagent Cards

    BioMérieux is recalling VITEK 2 Compact 15 software and reagent cards because they may fail to finalize test results after a software update.

    Product
    VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3044-2017·2017-09-06

    Neusoft Medical NeuViz 64 CT Scanner Software Defect Recall

    Neusoft Medical Systems is recalling 234 NeuViz 64 CT scanners due to a software defect. The FDA mandated this recall for units distributed nationwide.

    Product
    Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Sca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V485000·2017-08-02

    2017 Jeep Renegade Recall for Instrument Panel Software Defect

    Chrysler is recalling 2017 Jeep Renegade vehicles because a software issue may cause malfunction indicator lamps to illuminate incorrectly, potentially masking true vehicle faults.

    Product
    JEEP — JEEP RENEGADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2017·2017-07-26

    Agfa Healthcare Recalls NX 3.0.8950 Imaging Processing Software

    Agfa Healthcare is recalling NX 3.0.8950 software because it may temporarily display and transmit incorrect patient images to PACS systems.

    Product
    Agfa Healthcare NX 3.0.8950 Imaging Processing Software
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2732-2017·2017-07-19

    Nova Biomedical Stat Profile Prime Analyzer Software Recall

    Nova Biomedical is recalling Stat Profile Prime Analyzers because a software defect could cause scheduled quality control tests to overwrite pending patient results.

    Product
    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2684-2017·2017-07-12

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems Due to Software Issue

    Ion Beam Applications S.A. is voluntarily recalling six Proteus 235 Proton Therapy Systems worldwide due to a software issue. Five of these units are located in the United States.

    Product
    Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2628-2017·2017-07-05

    Merge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification

    Merge Healthcare is recalling specific versions of its LIS software because wrong laboratory results could be inadvertently verified under certain conditions.

    Product
    Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2017·2017-07-05

    Elekta MOSAIQ Oncology System Recalled for Care Plan Update Failure

    Elekta is recalling MOSAIQ Oncology Information System versions 2.50.05 and higher because outdated information may remain in order sets, potentially affecting treatment workflows.

    Product
    MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2620-2017·2017-06-28

    Merge OrthoPACS Software Recalled for Annotation Display Error

    Merge Healthcare is recalling Merge OrthoPACS software versions 6.6, 6.6.1, and 6.6.2 because prior studies may fail to display annotations.

    Product
    Merge OrthoPACS software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2601-2017·2017-06-28

    Merge OrthoPACS software recalled due to data propagation failures

    Merge Healthcare is recalling specific versions of Merge OrthoPACS software because studies may fail to transfer or import correctly between servers.

    Product
    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2017·2017-06-21

    GE Healthcare Discovery ML DR X-ray System Recalled for Scan Timing Issue

    GE Healthcare is recalling Discovery ML DR X-ray systems because a software issue may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare Discovery Ml DR X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2017·2017-06-21

    GE Healthcare Discovery IQ X-ray System Recalled for Scan Timing Issue

    GE Healthcare is recalling Discovery IQ X-ray systems because a software issue may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare Discovery IQ X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2186-2017·2017-06-21

    GE Healthcare Optima CT540 X-ray System Recalled for Scan Timing Issue

    GE Healthcare is recalling 10,884 Optima CT540 X-ray systems because a software issue may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare Optima CT540 X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2591-2017·2017-06-21

    Merge Healthcare Recalls Merge PACS Software Due to Image Display Defect

    Merge Healthcare is recalling specific versions of Merge PACS software because a display defect may cause image lines to shift, potentially leading to physician misdiagnosis.

    Product
    Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2017·2017-06-21

    Merge PACS Software Recalled for Potential Image Display Defect

    Merge Healthcare is recalling specific versions of Merge PACS software because unviewed images may not display correctly, posing a risk of physician misdiagnosis.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2017·2017-06-21

    GE Healthcare Recalls Innova IGS 540 ACT X-ray Systems

    GE Healthcare is recalling 10,884 Innova IGS 540 ACT X-ray systems because a software issue may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare lnnova IGS 540 ACT X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2017·2017-06-14

    Nexstim eXima NBS System Software Recalled for File Duplication Defect

    Nexstim PLC is recalling 11 units of the eXima NBS System due to a software defect that may generate duplicate files.

    Product
    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the a
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2320-2017·2017-06-14

    Nexstim Navigated Brain Stimulation System Software Defect Recall

    Nexstim PLC is recalling 21 units of the Navigated Brain Stimulation System due to a software defect that may generate duplicate files.

    Product
    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to i
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2157-2017·2017-05-31

    Beckman Coulter UniCel DxH 800 Recalled for Potential Data Errors

    Beckman Coulter is recalling UniCel DxH 800 systems because a software issue may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2017·2017-05-31

    Beckman Coulter UniCel DxH 600 Recall for Erroneous WBC Differential Results

    Beckman Coulter is recalling UniCel DxH 600 systems due to a software issue that may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2035-2017·2017-05-10

    Beckman Coulter AQUIOS CL Flow Cytometer Software Export Defect Recall

    Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the software's Export feature incorrectly handles Tetra Combo CRD files.

    Product
    AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two lig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2017·2017-04-26

    BD MAX System Software Version 4.44A Recalled for Potential Incorrect Results

    BD Life Sciences is recalling BD MAX System software version 4.44A due to a defect that may cause incorrect result reporting for specific user-defined protocol assays.

    Product
    Software version 4.44A utilized on the BD MAX System
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1830-2017·2017-04-26

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 Proton Therapy Systems because users may restart aborted irradiations without selecting correct data.

    Product
    Proteus 235, Proton Therapy System
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1828-2017·2017-04-26

    Merge Healthcare Recalls Eye Station and Eye Care PACS Software

    Merge Healthcare is recalling Eye Station and Eye Care PACS software because antivirus programs may permanently delete newly captured medical images.

    Product
    Merge Eye Station and Merge Eye Care PACS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V272000·2017-04-21

    Daimler Recalls 2013-2016 Sprinter and Metris Vehicles for Software Conflict

    Daimler Vans USA is recalling 2013-2014 Freightliner Sprinter and 2016 Mercedes-Benz Metris vehicles because software updates may conflict with vehicle computers, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, METRIS, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide