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.

476–500 of 1335

  • 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    GE Healthcare is recalling 526 Discovery NM 530c systems because outdated software caused a patient finger injury during an automatic unload process.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 th
    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 be
    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 calculat
    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
  • ModerateFDA (Devices)·Z-1797-2020·2020-05-06

    Siemens Atellica CH 930 Analyzer Recall for Software Defect

    Siemens is recalling Atellica CH 930 Analyzers with specific software versions due to a defect that may cause incorrect test results.

    Product
    Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1708-2020·2020-04-22

    United Imaging uMI 550 PET/CT System Recalled for Software Bugs

    Shanghai United Imaging Healthcare is recalling two uMI 550 PET/CT systems due to software bugs that may cause reconstruction problems and patient rescans.

    Product
    Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1679-2020·2020-04-15

    Siemens ONCOR Radiation Therapy Systems Recalled for Potential Dose Overdose

    Siemens is recalling specific ONCOR radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% overdose.

    Product
    ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1684-2020·2020-04-15

    Radiometer ABL800 FLEX Blood Gas Analyzer Barcode Reader Recall

    Radiometer Medical ApS is recalling ABL800 FLEX analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or sample loss.

    Product
    ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1617-2020·2020-04-08

    Haemonetics Recalls TEG Manager Software Due to Alert Display Defect

    Haemonetics is recalling TEG Manager software versions 1.1.0 through 4.1.1 because a defect causes incorrect out-of-range alerts for coagulation test results.

    Product
    TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2020·2020-03-25

    Siemens Artis Angiography Systems Recalled for Software Movement Blockage

    Siemens is recalling Artis angiography systems because a software issue could block stand and table movements.

    Product
    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2020·2020-03-25

    Siemens Artis Q Angiography Systems Recalled for Software Movement Issue

    Siemens is recalling Artis Q angiography systems because a software issue could block stand and table movements.

    Product
    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervention
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1496-2020·2020-03-25

    Siemens Artis Q.zen Angiography Systems Recalled for Software Movement Issue

    Siemens is recalling Artis Q.zen angiography systems because a software issue could block stand and table movements.

    Product
    Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation 8B software system in Tennessee due to a defect that causes incorrect position values when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1463-2020·2020-03-18

    RayStation Software Recall for Potential Treatment Planning Errors

    RaySearch Laboratories is recalling one RayStation 8A system in Tennessee due to a software defect that may cause incorrect treatment planning calculations.

    Product
    RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1462-2020·2020-03-18

    RayStation 8A Software Recalled for Treatment Planning Calculation Errors

    RaySearch Laboratories is recalling RayStation/RayPlan 8A software due to a defect that causes incorrect treatment planning values when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1359-2020·2020-03-11

    CareFusion Alaris PC Unit Software Error Recall

    CareFusion is recalling Alaris PC units due to software errors that may cause infusion interruptions, alarm failures, or incorrect medication concentrations.

    Product
    CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
    Category
    Medical Device
    Distribution
    Distributed nationwide