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.

1101–1125 of 1375

  • HighFDA (Devices)·Z-0236-2015·2014-12-24

    Philips Brilliance iCT Computed Tomography System Software Defect Recall

    Philips Medical Systems is recalling 16 Brilliance iCT Computed Tomography X-Ray Systems due to a software defect that may prevent scans from terminating at the intended location.

    Product
    Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0507-2015·2014-12-17

    TomoTherapy Treatment System Recalled for Jaw Position Monitoring Failure

    TomoTherapy Incorporated is recalling 210 TomoTherapy Treatment Systems worldwide due to a software defect that may fail to monitor jaw position after an error, potentially leading to incorrect treatment delivery.

    Product
    TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2015·2014-12-17

    Mevion S250 Proton Therapy System Recalled for Software Defect

    Mevion Medical Systems is recalling one MEVION S250 proton therapy system in Missouri due to a software defect that may cause incorrect dose delivery.

    Product
    MEVION S250, used for proton radiation therapy.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0486-2015·2014-12-10

    Siemens Artis zee Angiography System Software Recall

    Siemens is recalling 1,131 Artis zee and zeego Angiography Systems due to a software issue that prevents deactivating the radiation block function after a network problem.

    Product
    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2015·2014-12-03

    Philips IntelliSpace Portal Software Defect May Display Incorrect Cardiac Measurements

    Philips is recalling 32 IntelliSpace Portal systems due to a software defect that may display incorrect cardiac and aortic anatomy measurements used for sizing Transcatheter heart valves.

    Product
    IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0450-2015·2014-12-03

    Philips BrightView Ultrasound Systems Recalled for Software Issues

    Philips Medical Systems is recalling 85 BrightView ultrasound systems worldwide due to software issues. The voluntary recall was initiated in November 2014.

    Product
    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0218-2015·2014-11-26

    Accuray Recalls CyberKnife Robotic Radiosurgery Systems Due to Software Upgrade Issue

    Accuray is recalling 84 CyberKnife Robotic Radiosurgery Systems to correct a potential safety issue related to upgrading the Treatment Delivery Software for the first generation IRIS Variable Aperture Collimator.

    Product
    CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0222-2015·2014-11-26

    Nidek MC-500 Laser Photocoagulator Recalled for Unreported Engineering Change

    Nidek Inc is recalling five MC-500 Multicolor Laser Photocoagulators because an engineering change order regarding a memory function problem was not reported as required.

    Product
    MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0105-2015·2014-10-29

    Philips Avalon Fetal Monitors Recalled for Software Measurement Error

    Philips is recalling Avalon fetal monitors with specific software because automatic blood pressure measurements stop in certain modes.

    Product
    Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2015·2014-10-29

    Philips IntelliVue Monitors Recalled for NBP Measurement Stoppage

    Philips is recalling IntelliVue monitors with specific software revisions because the automatic blood pressure measurement series stops in time-synchronized mode.

    Product
    Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0107-2015·2014-10-29

    Mindray V-Series Patient Monitor Recalled for Drug Calculator Function Issue

    Mindray DS USA is voluntarily recalling V-Series Patient Monitors due to a software issue with the Drug Calculator function.

    Product
    Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2015·2014-10-22

    Intuitive Surgical Recalls EndoWrist One Vessel Sealer for Labeling and Software Issues

    Intuitive Surgical is voluntarily correcting labeling and software for the EndoWrist One Vessel Sealer used with the da Vinci Si Surgical System.

    Product
    EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2707-2014·2014-10-01

    Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode

    Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.

    Product
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2708-2014·2014-10-01

    Dako Autostainer Link 48 Software Recall for Reagent Handling Issues

    Dako is recalling software for the Autostainer Link 48 because an upgrade may cause premature reagent rejection or inadequate aspiration if specific maintenance conditions are met.

    Product
    Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2653-2014·2014-09-24

    Mitsubishi Vero Linear Accelerator Software Recall for Treatment Status Errors

    Mitsubishi Heavy Industries is recalling three Vero Linear Accelerator systems in the US due to a software defect that may incorrectly mark completed radiation treatments as untreated.

    Product
    VERO Linear Accelerator System, Model Number MHI-TM2000; 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
    3 states
  • ModerateFDA (Devices)·Z-2665-2014·2014-09-24

    Siemens CentraLink Data Management System Software Recall for Timer Overflow

    Siemens is recalling CentraLink Data Management System software version 14 due to a task scheduler issue that may stop command execution and result uploads.

    Product
    Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2664-2014·2014-09-24

    Philips CT Systems Recalled for Software Image Overlap Defect

    Philips is recalling Brilliance 64 and Ingenuity CT systems because CIRS 4.0 Beta 2 software may cause images to overlap during reconstruction.

    Product
    The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2597-2014·2014-09-17

    Radiometer America Recalls RADIANCE Clinical Data Processing Software Versions 2.4X to 2.6X

    Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.

    Product
    RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2574-2014·2014-09-10

    Elekta FOCAL Sim Workstation Software Recall for Plan Mismatch

    Elekta is recalling FOCAL Sim Workstation software versions 4.70.00 and 4.80.00 because exported arc plans may not match approved treatment plans.

    Product
    FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2014·2014-09-10

    Elekta Monaco System Recalled for Incorrect Radiation Treatment Plan Delivery

    Elekta is recalling Monaco software versions 3.20.00 and higher because exported VMAT plans may not match approved treatment plans.

    Product
    Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2014·2014-08-20

    Brainlab Navigation Spine & Trauma 3D Software Recalled for Registration Error

    Brainlab AG is recalling 17 Navigation Spine & Trauma 3D software systems worldwide due to a defect in automatic CT image registration.

    Product
    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2235-2014·2014-08-20

    Vital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch

    Nellcor Puritan Bennett Inc. is correcting Vital Sync Virtual Patient Monitoring Platform units due to a mismatch between device alarm priorities and the system.

    Product
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2180-2014·2014-08-20

    Siemens Syngo RT Software Recalled for Sporadic System Crashes

    Siemens is recalling Syngo RT Therapist and Oncologist software versions 4.3.SP1 due to sporadic system crashes that prevent unloading patient data.

    Product
    Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2146-2014·2014-08-13

    Brainlab ExacTrac Software Recall for Potential Radiation Misalignment

    Brainlab AG is recalling ExacTrac v6.0.4 software because it may move patients to the wrong position during radiation treatment, potentially delivering the dose to an unintended target.

    Product
    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2121-2014·2014-08-06

    McKesson Horizon Medical Imaging Software Recalled for Image Index Discrepancy

    McKesson Medical Imaging is recalling Horizon Medical Imaging software due to a defect that may cause a mismatch between the expected image index and the actual folder content.

    Product
    Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical…
    Category
    Medical Device
    Distribution
    48 states