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.

501–525 of 1375

  • ModerateFDA (Devices)·Z-2510-2020·2020-07-15

    Medtronic Azure S SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 11,953 Azure S SR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Azure S SR MRI, Model Number W3SR01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2437-2020·2020-07-08

    Siemens CentraLink Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling CentraLink Data Management System software versions 16.0.2 and 16.0.3 due to a defect that may cause erroneous patient results.

    Product
    (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2438-2020·2020-07-08

    Siemens Atellica Data Manager Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling Atellica Data Manager software versions 1.0 and 1.1 because unexpected interface driver behavior may cause quality control results to be assigned to incorrect control lot numbers, potentially leading to the reporting of erroneous patient results.

    Product
    (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2020·2020-07-08

    Fujifilm Synapse PACS Software Recalled for Incorrect Orientation Markers

    Fujifilm is recalling Synapse PACS Software versions 5.5.x and 5.7.x because incorrect orientation markers and slice locations may lead to misdiagnosis.

    Product
    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2020·2020-07-08

    United Imaging uCT 530 CT System Recalled for Scanning Interruptions

    Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-Ray Systems in Texas due to software issues that may cause scanning interruptions or image artifacts.

    Product
    uCT 530 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2482-2020·2020-07-08

    Ortho VITROS 5600 Software Recall for Parameter Reset Defect

    Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and below because assay parameters may reset to defaults.

    Product
    VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2484-2020·2020-07-08

    Ortho VITROS XT 7600 Software Recall for Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System software versions 3.5.1 and below because MicroWell Qualitative Assay parameters may reset to defaults.

    Product
    VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2020·2020-07-08

    Ortho VITROS 3600 System Recalled for Assay Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling 27 refurbished VITROS 3600 Immunodiagnostic Systems because assay parameters may reset to defaults, potentially affecting test results.

    Product
    VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2483-2020·2020-07-08

    Ortho VITROS 5600 System Recall for Software Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling 130 refurbished VITROS 5600 Integrated Systems because software modifications to assay parameters may be inadvertently reset to default.

    Product
    VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2480-2020·2020-07-08

    Ortho VITROS 3600 Software Recall for Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System software versions 3.3.3 and below because MicroWell Qualitative Assay parameters may reset to defaults.

    Product
    VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V395000·2020-07-06

    Mercedes-Benz Recalls AMG Models Due to Electronic Stability Control Software Error

    Mercedes-Benz is recalling 2019-2020 AMG models because incorrect Electronic Stability Program software may cause the system to react inaccurately, increasing the risk of a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT63S, AMG GLC63 S, AMG GT63, AMG C63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2020·2020-07-01

    GE Healthcare Recalls CARESCAPE Patient Data Modules Due to False Alarms

    GE Healthcare is recalling CARESCAPE Patient Data Modules because they may display false flat-line ECGs and asystole alarms when used with an AED.

    Product
    CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2297-2020·2020-06-17

    Elekta Unity Software Recall for Motion Monitoring Data Mismatch

    Elekta Limited is recalling specific Unity software versions due to a potential mismatch between contour data and motion monitoring images.

    Product
    Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2258-2020·2020-06-10

    GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect

    GE Healthcare is recalling 526 Nuclear Medicine systems because outdated software caused a patient's finger to be injured during an automatic unload process.

    Product
    System, Tomography Computed Emmission
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-2257-2020·2020-06-10

    Siemens ARTIS icono X-Ray Systems Recalled for Incorrect Vessel Quantification

    Siemens is recalling five ARTIS icono X-ray systems because software may fail to detect vessels or provide incorrect measurements, potentially leading to wrong diagnoses.

    Product
    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2259-2020·2020-06-10

    GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect

    GE Healthcare is recalling 526 Discovery NM 530c systems because outdated software caused a patient finger injury during an automatic unload process.

    Product
    System, Tomography Computed Emmission
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2246-2020·2020-06-10

    Hill-Rom Centrella Smart+ Bed Recall for Alert System Failure

    Hill-Rom is recalling 4,381 Centrella Smart+ Beds because the Bed Exit System may fail to send remote alerts to the nurse call system under specific conditions.

    Product
    Centrella Smart+ Bed, Catalog Number P7900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2020·2020-05-27

    Binding Site Optilite Clinical Chemistry Analyzer Recalled for Software Accuracy Issue

    The Binding Site Group is recalling 36 Optilite Clinical Chemistry Analyzers due to a software issue that may affect result accuracy.

    Product
    The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2020·2020-05-20

    CuattroDR System Software Recalled for Potential Image Misattribution

    Cuattro LLC is recalling CuattroDR System Software because images from previous patient studies may appear in later studies, potentially leading to misdiagnosis.

    Product
    CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1899-2020·2020-05-13

    Varian Multileaf Collimator Recall Due to Software-Related Leaf Movement Failure

    Varian Medical Systems is recalling 151 Multileaf Collimators because a software upgrade caused leaves to fail to move during specific arc treatments.

    Product
    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2020·2020-05-13

    ICU Medical Recalls Cogent Hemodynamic Monitoring System Due to Software Defect

    ICU Medical is recalling 123 units of the Cogent Hemodynamic Monitoring System because a software issue prevents the system from storing patient IDs and information.

    Product
    The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V262000·2020-05-08

    Ford Recalls 2020 Expedition and Navigator for Pre-Collision Assist Defect

    Ford is recalling 2020 Expedition and Lincoln Navigator vehicles because the Pre-Collision Assist feature is not enabled due to incorrect coding, increasing crash risk.

    Product
    FORD — FORD, LINCOLN EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1825-2020·2020-05-06

    Elekta MONACO RTP System Recalled for Potential Inaccurate Radiation Dose Delivery

    Elekta Inc is recalling 96 MONACO RTP systems because the software may alter contour shapes, potentially resulting in inaccurate radiation dose delivery to patients.

    Product
    Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2020·2020-05-06

    ViewRay MRIdian TPDS Software Recalled for Dose Alignment Errors

    Viewray, Inc. is recalling 32 units of MRIdian TPDS software due to a defect that may cause incorrect dose calculations during treatment planning.

    Product
    ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1835-2020·2020-05-06

    ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issues

    ICU Medical is recalling 83 Cogent Hemodynamic Monitoring Systems due to software issues that may cause inaccurate data, unit shutdown, or loss of display.

    Product
    ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
    Category
    Medical Device
    Distribution
    Distributed nationwide