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.

476–500 of 1375

  • HighFDA (Devices)·Z-0434-2021·2020-11-18

    Inpeco Aptio Automation System Recall for Potential Sample Dilution

    Inpeco S.A. is recalling 104 Aptio Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.

    Product
    Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0433-2021·2020-11-18

    Inpeco Accelerator a3600 Aliquoter Module Recall for Sample Dilution Risk

    Inpeco S.A. is recalling 136 Accelerator a3600 Automation Systems with Aliquoter Modules due to a software error that may dilute samples with water, leading to erroneous test results.

    Product
    Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0400-2021·2020-11-11

    Siemens ARTIS Icono X-Ray System Recalled for Software Misalignment

    Siemens is recalling ARTIS Icono X-ray systems due to a software defect that may cause inaccurate image overlays, potentially leading to patient danger.

    Product
    ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2021·2020-11-11

    Boston Scientific Recalls LATITUDE Programming Systems Due to Software Defect

    Boston Scientific is recalling eight Model 3300 LATITUDE Programming Systems because a software defect may cause EGM trace channels to display as a flat line during specific tests.

    Product
    Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0282-2021·2020-10-28

    Fujifilm Synapse PACS Software Version 5.6.1 Recalled for CT Measurement Error

    Fujifilm is recalling Synapse PACS Software Version 5.6.1 because certain CT studies may report inaccurate 3D Sphere MAX values.

    Product
    Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0056-2021·2020-10-14

    Brainlab Ultrasound Navigation Software Recalled for Image Width Limitation

    Brainlab AG is recalling Ultrasound Navigation Software 1.0 and related integration software because the system does not support modifying the probe's image width.

    Product
    Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3025-2020·2020-10-07

    Siemens CT Software Recall for Workflow Interruptions and Diagnostic Delays

    Siemens Medical Solutions is recalling syngo.CT software versions VB20 and VB20_SP1 for 767 CT systems due to sporadic workflow interruptions that may delay diagnosis or require patient rescans.

    Product
    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2974-2020·2020-09-23

    Inpeco FlexLab 3.6 Automation Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling 8 FlexLab 3.6 Automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed clinical chemistry results.

    Product
    Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2956-2020·2020-09-23

    Novarad Recalls NovaPACS Diagnostic Viewer Software Due to Image Placement Error

    Novarad Corporation is recalling NovaPACS Diagnostic Viewer software because the cross-localization feature may inaccurately place reference lines on asymmetrical images.

    Product
    NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2880-2020·2020-09-02

    Biosense Webster Recalls CARTO 3 System Software Due to Defect

    Biosense Webster is recalling the CARTO 3 System software due to a defect that may cause tag sites to disappear, potentially leading to cardiac perforation.

    Product
    CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2819-2020·2020-08-26

    United Imaging uMI 550 PET/CT Systems Recalled for Software Display Issue

    Shanghai United Imaging Healthcare Co., Ltd. is recalling three uMI 550 PET/CT systems because a software defect may prevent the CT Hounsfield unit curve from displaying in real time during specific scans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2773-2020·2020-08-19

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling four Proteus 235 Proton Therapy Systems because a software defect prevents users with long names from resuming interrupted treatments.

    Product
    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2715-2020·2020-08-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 proton therapy systems because aborted irradiations cannot be resumed due to a software loading issue.

    Product
    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2688-2020·2020-07-29

    Siemens syngo.via RT Image Suite Software Recall for Geometry Errors

    Siemens is recalling syngo.via RT Image Suite software versions VB30 and VB40 because modified MR image orientations may result in incorrect geometry and radiation treatment plans.

    Product
    syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V439000·2020-07-28

    Honda Odyssey, Passport, and Pilot instrument panel and rearview camera software failure

    Honda is recalling 2018-2020 Odyssey, 2019-2020 Passport, and 2019-2021 Pilot vehicles with software causing the instrument panel to fail to display critical information (engine oil pressure, speedometer, gear position) and preventing the rearview camera image from displaying.

    Product
    HONDA — HONDA PILOT, ODYSSEY, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2020·2020-07-15

    Ra Medical Systems Recalls DABRA Laser Due to Software Issue

    Ra Medical Systems is recalling 79 DABRA Laser units because a software issue could cause unintended laser light release, potentially injuring users or patients.

    Product
    DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The…
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2537-2020·2020-07-15

    Vitalconnect VistaSolution Software Recall for Missing SpO2 Notifications

    Vitalconnect Inc. is recalling VistaSolution software due to a defect that prevented low SpO2 alerts, potentially exposing patients to short-term hypoxia.

    Product
    VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2020·2020-07-15

    Radiometer ABL800 FLEX Blood Gas Analyzer Software Recall

    Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that may cause patient mix-ups.

    Product
    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2493-2020·2020-07-15

    Radiometer ABL800 FLEX Blood Gas Analyzers Recalled for Software Issues

    Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that creates a potential risk of patient mix-up.

    Product
    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and…
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2505-2020·2020-07-15

    Medtronic Recalls CareLink SmartSync Device Manager Due to Feature Suspension

    Medtronic is recalling 2,773 CareLink SmartSync Device Manager units worldwide because a rare communication error may temporarily suspend certain device features.

    Product
    CareLink SmartSync Device Manager, Model Number 24970A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2509-2020·2020-07-15

    Medtronic Azure XT SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 31,736 Azure XT SR MRI devices due to a rare communication issue that temporarily suspends certain device features.

    Product
    Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
    Category
    Medical Device
    Distribution
    0 states