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.

Which agencies issued them

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.

1051–1075 of 1335

HighFDA (Devices)·Z-1267-2015·2015-03-18
Siemens CT System Recalled for Image Artifacts and Safety Issues
Siemens Medical Solutions is recalling 12 SOMATOM Force CT systems due to potential image artifacts and safety-related software issues.
Product
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1237-2015·2015-03-11
Elekta Monaco Radiation Therapy System Recalled for Incorrect CT to ED Conversion
Elekta, Inc. is recalling Monaco radiation therapy treatment planning systems because the Image Statistics Tool may incorrectly convert CT to ED values.
Product
Monaco radiation therapy treatment planning system. 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-
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1214-2015·2015-03-04
GE Healthcare Recalls Centricity PACS Workstation Due to Exam Merge Failure
GE Healthcare is recalling 128 Centricity PACS Workstation systems because a software defect may cause exam records to go missing in single Study Mode.
Product
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review work
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2015·2015-02-11
SCC Soft Computer Recalls SoftLab Laboratory Information System Versions
SCC Soft Computer is recalling SoftLab versions 4.0.7.0 and 4.0.7.1 because the software fails to send abnormal flags for Reference Lab test results.
Product
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1049-2015·2015-02-11
Carl Zeiss Meditec FORUM Archive and Viewer Software Recall
Carl Zeiss Meditec is recalling FORUM Archive and Viewer software versions 3.1 and 3.2 due to a defect that may lead to misinterpretation of optical coherence tomography data.
Product
FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive wi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1011-2015·2015-02-04
Philips BrightView MRI Systems Recalled for Unintended Movement
Philips is recalling 1,064 BrightView MRI systems worldwide due to software issues causing unintended detector and gantry movement.
Product
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1027-2015·2015-02-04
Siemens Syngo.plaza PACS Recalled for Potential Image Loss During System Crashes
Siemens Medical Solutions is recalling 50 Syngo.plaza PACS systems because images may be lost if the system crashes before saving data to the hard disk.
Product
Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also suppor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2015·2015-01-28
Siemens Radiographic Systems Recalled for Potential Image Flipping Errors
Siemens is recalling 11 Ysio Max, Luminos dRF Max, and Agile Max systems because software errors may cause images to flip, leading to incorrect labels and potential misdiagnosis.
Product
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skul
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0956-2015·2015-01-21
Brainlab iPlan RT Dose Software Recalled for Potential Positioning Errors
Brainlab AG is recalling iPlan RT Dose software because it may produce incorrect patient positioning when using multiple CT image data sets.
Product
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-0957-2015·2015-01-21
Brainlab iPlan RT Software Recalled for Potential Incorrect Patient Positioning
Brainlab AG is recalling iPlan RT radiation treatment planning software due to a risk of incorrect patient positioning when using multiple localized CT image data sets.
Product
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Category
Medical Device
Distribution
45 states
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 ang
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 f
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 3
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 f
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 se
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