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.

951–975 of 1375

  • ModerateFDA (Devices)·Z-1575-2016·2016-05-04

    Mindray Panorama Patient Monitoring Network Recalled for Date Reversion

    Mindray DS USA is recalling Panorama Patient Monitoring Network units that may revert to the year 2000 during Daylight Savings Time.

    Product
    Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·16V257000·2016-04-28

    GM Recalls 2013-2016 Chevrolet Vehicles for Theft Protection Software Defect

    General Motors is recalling certain 2013-2016 Chevrolet Sonic, Trax, and Spark vehicles because the radio software may fail to provide an audible warning chime, increasing the risk of vehicle theft.

    Product
    CHEVROLET — CHEVROLET TRAX, SPARK, SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2016·2016-04-27

    Siemens SOMATOM Definition Flash CT Systems Recalled for Software Bugs

    Siemens Medical Solutions is recalling 1,096 CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.

    Product
    Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1500-2016·2016-04-27

    Siemens ADVIA 560 Hematology System Software Recall

    Siemens is recalling ADVIA 560 Hematology Systems because a software defect prevents the system from flagging immature granulocytes and atypical lymphocytes in patient samples.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1518-2016·2016-04-27

    Siemens SOMATOM Definition CT Systems Recalled for Software Bugs

    Siemens Medical Solutions USA is recalling 1,096 SOMATOM Definition CT systems due to software bugs that may cause scan aborts, re-scans, or accidental radiation.

    Product
    Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1519-2016·2016-04-27

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bugs

    Siemens is recalling 1,096 SOMATOM Definition AS CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.

    Product
    Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1504-2016·2016-04-27

    Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

    Philips Medical Systems is recalling the AutoSPECT Pro software application because it may produce erroneous results when processing cardiac SPECT data acquired at detector angles other than 90 or 180 degrees.

    Product
    Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1379-2016·2016-04-20

    Stryker SurgiCounter Scanner Recalled for Software Interaction Errors

    Stryker is recalling 286 SurgiCounter scanners because they may display error messages and fail to display software version numbers correctly in the SC360 application.

    Product
    SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1309-2016·2016-04-06

    ViewRay MRIdian Radiation Therapy System Software Recall

    ViewRay is recalling 5 MRIdian Radiation Therapy Systems due to a software defect that may fail to prompt users to shift the couch to a new isocenter during re-optimization.

    Product
    MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1308-2016·2016-04-06

    Mitsubishi VERO MHI-TM2000 Linear Accelerator Recall for Gantry Angle Error

    Mitsubishi Heavy Industries is recalling VERO MHI-TM2000 Linear Accelerators because the operator console may set an incorrect gantry angle for the first beam of an IMRT treatment.

    Product
    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2016·2016-04-06

    Siemens Recalls Cios Alpha Mobile X-Ray Systems Due to Software Issues

    Siemens Medical Solutions is recalling 89 Cios Alpha mobile X-ray systems due to software issues. The units were distributed nationwide to 30 states.

    Product
    Cios Alpha, mobile X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1249-2016·2016-04-06

    Medtronic Recalls Reveal LINQ Cardiac Monitor Due to Algorithm Sensitivity Issue

    Medtronic is recalling Reveal LINQ insertable cardiac monitors because an algorithm issue may trigger replacement alerts prematurely. The device battery and data collection capabilities remain functional.

    Product
    Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2016·2016-03-23

    McKesson Medical Imaging Software Recalled for Potential Image Display Errors

    McKesson is recalling Horizon Medical Imaging and Radiology software due to a design deficiency that may cause incorrect patient images to be displayed.

    Product
    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1183-2016·2016-03-23

    Siemens Syngo Dynamics PACS Software Recall for Measurement Package Issue

    Siemens is recalling Syngo Dynamics PACS software due to a potential issue in the VA10 measurement package. 228 units are affected nationwide.

    Product
    Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2016·2016-03-16

    Philips Respironics Recalls Trilogy and Garbin Ventilators Due to Software Issue

    Philips Respironics is recalling approximately 104,508 Trilogy and Garbin ventilators due to a software issue. The recall covers units distributed nationwide and internationally.

    Product
    Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1075-2016·2016-03-16

    Ortho-Clinical VITROS 5,1 FS Chemistry System Recall for Software Defect

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to increased error codes generated when using a specific calibrator lot.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0862-2016·2016-03-02

    Siemens Recalls Syngo Plaza PACS Software Due to Display and Access Issues

    Siemens is recalling 68 units of Syngo Plaza PACS software to fix bugs affecting image display, saving, and access controls.

    Product
    Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0803-2016·2016-03-02

    Olympus Delta XRF Analyzer Recalled Due to Software Bug

    Olympus Scientific Solutions Americas is recalling Delta XRF Analyzers because the firm discovered a software bug.

    Product
    Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V113000·2016-02-26

    Chrysler Recalls 2015-2016 Dodge Dart Vehicles for Software Defect

    Chrysler is recalling certain 2015 and 2016 Dodge Dart vehicles because a missing software backup in the powertrain control module may increase the risk of a crash.

    Product
    DODGE — DODGE DART
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.

    Product
    INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2016·2016-02-10

    Philips Allura Xper X-ray Systems Recalled for Image Display Error

    Philips is recalling Allura Xper FD10/10 systems because a software issue may cause still images to be mistaken for live images during X-ray procedures.

    Product
    Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2016·2016-02-10

    Philips UNIQ and Allura Systems Recall for Image Interpretation Error

    Philips is recalling UNIQ and Allura systems because a software issue may cause still images to be misinterpreted as live images during medical procedures.

    Product
    UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0702-2016·2016-02-10

    Philips Allura Xper X-ray Systems Recalled for Image Interpretation Error

    Philips is recalling Allura Xper FD10 systems because a software defect may cause still images to be mistaken for live images during cardiovascular procedures.

    Product
    Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.

    Product
    INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
    Category
    Medical Device
    Distribution
    Distributed nationwide