The Recall Desk

Hazard

Software Bug recalls

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

What the numbers show

Total
51
Critical
0
Severe
4
Most recent
2026-08-12

Of the 51 software bug recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (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 bug 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.

1–25 of 51

  • HighFDA (Devices)·Z-2874-2026·2026-08-12

    Merge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error

    Merge Healthcare is recalling 53 Merge PACS medical imaging workstations due to a software issue where thumbnails from one patient's study may incorrectly display when viewing a different patient's study, potentially compromising patient confidentiality.

    Product
    Merge PACS, medical imaging diagnostic workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2026·2026-07-29

    MiniMed Go App Recalled Due to Missed Insulin Alerts

    Medtronic is recalling its MiniMed Go app because a software bug can prevent insulin dose alerts during nighttime, potentially leading to missed doses and hyperglycemia.

    Product
    MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2026·2025-12-24

    Imaging viewer software recalled over inaccurate length measurement values

    DICOM Grid is recalling 924 units of Intelerad InteleShare software because a bug can produce inaccurate length measurement tool values that could lead to misdiagnosis.

    Product
    Intelerad InteleShare software, with ProViewer component
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0723-2026·2025-12-03

    Imaging software recalled over a bug that can lose clinical information

    Intelerad Medical Systems is recalling 19 IntelePACS InteleConnect and TechPortal installations because a bug can cause data loss in the Relevant Clinical Info field.

    Product
    IntelePACS - InteleConnect / TechPortal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2025·2025-06-18

    EPIONE Stereotactic Device Software Bug Poses Instrument Guidance Risk

    The EPIONE Model 30-0001 stereotactic device is recalled due to a software bug that may cause the robotic arm to incorrectly guide surgical instruments during CT-guided ablation procedures. Four units have been distributed in the U.S.

    Product
    EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2025·2025-06-11

    Dexcom G7 iOS App version 2.7.0 stops updating glucose readings

    Dexcom G7 iOS App version 2.7.0 can enter a state where glucose readings freeze and alerts do not trigger, risking missed detection of dangerously high or low blood sugar. Other connected devices like Apple Watch and insulin pumps continue to receive glucose data directly from the transmitter.

    Product
    Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1738-2025·2025-05-14

    Blueprint Software version 4.2.1 surgical planner access bug

    Tornier's Blueprint Software version 4.2.1 contains a bug that prevents surgeons from accessing surgical cases created in earlier software versions.

    Product
    Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2025·2025-04-16

    BD Pyxis automated dispensing cabinets recalled for software dosing bug

    CareFusion 303 is recalling BD Pyxis MedBank and MedFlex automated dispensing cabinets due to a software bug that prevents accurate tracking of medication quantities, potentially causing patients to receive more than the intended dose.

    Product
    BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2025·2025-02-26

    RayStation radiation therapy software recall for density calculation inconsistency

    RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0683-2025·2025-01-01

    Blood glucose ketone meter software bug causes erroneous result transmission

    Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.

    Product
    StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0681-2025·2025-01-01

    Glucose Hospital Meter Software Bug Transmits Inaccurate Results

    StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.

    Product
    StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2455-2024·2024-08-07

    Clinical Chemistry Analyzer Software Bugs May Cause Erroneous Patient Results

    Beckman Coulter's DxC 500 AU analyzer has two software bugs that may cause erroneous patient results due to misreported calibrations or expired reagents. No injuries or illnesses have been reported.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2024·2024-02-28

    Radiation Oncology Treatment Planning Software VERIQA Calculation Error

    PTW-FREIBURG's VERIQA software (versions 2.0 and 2.1) may incorrectly calculate gamma passing rates when users exclude voxels below a dose threshold, potentially displaying false positive dose evaluation results.

    Product
    Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1175-2024·2024-02-28

    Automated Impella Controller Software Update Resolves Pump Recognition Issue

    Abiomed is releasing software Version 8.5 for the Automated Impella Controller to fix an issue in versions 8.4 and 8.4.1 where the device failed to recognize the pump. Approximately 4,463 units were distributed nationwide.

    Product
    Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2023·2023-07-05

    RayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation

    RaySearch America is recalling RayStation radiation therapy treatment planning software due to a software bug that produces incorrect dose calculations. The error could lead to inappropriate treatment plans being approved for patient use.

    Product
    Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0960-2023·2023-02-01

    Getinge Flow-c Anesthesia System Software Bug May Prevent Ventilation

    The Getinge Flow-c Anesthesia System contains a software bug that can prevent pressure buildup and ventilation delivery. Under certain conditions, oxygen delivery may decrease, which may lead to hypoventilation and hypoxia.

    Product
    Getinge Flow-c Anesthesia System, Part No. 6887700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2022·2022-05-04

    Medtronic InterStim Clinician Software Has Data Loss Anomaly Affecting Patient Information

    The InterStim X Clinician software used to program urinary incontinence therapy has a software bug that causes patient information to be lost and display a 'Data Lost' notification.

    Product
    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) Inte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2022·2022-04-20

    ARIA Radiation Therapy Management Software May Cause Treatment Location Error

    Varian ARIA radiation therapy management software versions 13.6 through 16.1 may generate incorrect treatment plan values that could direct radiation therapy to the wrong location. No illnesses have been reported.

    Product
    ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2020·2020-05-06

    Boston Scientific Recalls iLab Polaris Systems Due to Data Archiving Bug

    Boston Scientific is recalling 150 iLab Polaris and Ultrasound systems in Europe because a software bug prevents specific data from being archived without notifying the user.

    Product
    iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1338-2020·2020-02-26

    Siemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images

    Siemens is recalling 475 Luminos Agile Max devices due to a software bug that may assign one image to two patients, potentially affecting diagnosis.

    Product
    Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeleta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2020·2020-02-26

    Siemens Ysio Max Radiographic System Recalled for Software Bug

    Siemens Medical Solutions is recalling 507 Ysio Max radiographic systems because a software bug may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on ped
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2020·2020-02-26

    Siemens Luminos dRF Max Recalled for Software Bug Affecting Patient Images

    Siemens Medical Solutions USA, Inc. is recalling 46 Luminos dRF Max digital radiography systems due to a software bug that may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2020·2019-12-25

    Polymer Technology Systems Recalls A1CNow SELF CHECK Software Bug

    Polymer Technology Systems is recalling A1CNow SELF CHECK devices due to a software bug that may display incorrect numerical values instead of expected symbols.

    Product
    A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0684-2020·2019-12-25

    Polymer Technology Systems Recalls Walgreens At-Home A1C Test Kits

    Polymer Technology Systems is recalling 15,118 Walgreens At-Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.

    Product
    Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
    Category
    Medical Device
    Distribution
    18 states