The Recall Desk

Hazard

Software Error recalls

482 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
482
Critical
2
Severe
26
Most recent
2026-08-12

Of the 482 software error recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (5%) 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 error 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.

326–350 of 482

  • ModerateFDA (Devices)·Z-1353-2016·2016-04-20

    Philips Brilliance iCT SP CT Systems Recalled for Software Error

    Philips is recalling 49 Brilliance iCT SP CT systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Brilliance iCT SP 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
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1394-2016·2016-04-20

    Alcon Recalls VERION Reference Units Due to Surgical Plan Errors

    Alcon is voluntarily recalling 97 VERION Reference Units because unplanned arcuate lines may appear on printed or exported surgical plans.

    Product
    VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1355-2016·2016-04-20

    Philips Ingenuity Core 128 CT Systems Recalled for Software Error

    Philips is recalling 174 Ingenuity Core 128 CT systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Ingenuity Core 128 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
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1356-2016·2016-04-20

    Philips Ingenuity CT Systems Recalled for Software Error in Data Transmission

    Philips Medical Systems is recalling 82 Ingenuity CT systems due to a software error that may prevent the automatic transmission of image data to remote devices.

    Product
    Ingenuity CT 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
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1354-2016·2016-04-20

    Philips Ingenuity Core CT Systems Recalled for Software Error

    Philips is recalling 88 Ingenuity Core CT systems because a software error may prevent automatic transmission of image data to remote devices.

    Product
    Ingenuity Core 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
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1352-2016·2016-04-20

    Philips Brilliance iCT CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 324 Brilliance iCT Computed Tomography systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Brilliance iCT 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
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1351-2016·2016-04-20

    Philips Brilliance 64 CT Systems Recalled for Software Data Transmission Error

    Philips Medical Systems is recalling 285 Brilliance 64 CT systems because a software error may prevent the automatic transmission of all image and data series to remote devices.

    Product
    Brilliance 64: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
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1282-2016·2016-04-06

    Siemens Artis One X-Ray System Recalled for Data Mirroring Error

    Siemens is recalling one Artis One angiography system because imported left atrium segmentation results may be incorrectly mirrored to a 3D mapping system.

    Product
    Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2016·2016-04-06

    Beckman Coulter Recalls MicroScan LabPro Software Due to Editing Error

    Beckman Coulter is recalling MicroScan LabPro software because it allows incorrect manual editing of carbohydrate substrates for specific test panels.

    Product
    MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update K
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1175-2016·2016-03-30

    Toshiba DRAD-3000E Wireless System Recalled for Image Transmission Failure

    Toshiba is recalling 28 DRAD-3000E FPD Wireless Systems because they fail to complete image transmission, resulting in no radiographic image.

    Product
    Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1232-2016·2016-03-30

    Siemens syngo X Workplace Medical Workstation Recalled for Segmentation Error

    Siemens Medical Solutions USA is recalling six syngo X Workplace medical workstations because imported segmentation results appear mirrored, rendering them unusable for ablation procedures.

    Product
    syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1072-2016·2016-03-16

    Ortho-Clinical VITROS 350 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to increased error codes when using specific calibrators.

    Product
    VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1074-2016·2016-03-16

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to increased error codes when using a specific calibrator kit.

    Product
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1071-2016·2016-03-16

    Ortho-Clinical VITROS 250 Chemistry Systems Recalled for Condition Code Errors

    Ortho-Clinical Diagnostics is recalling VITROS 250 Chemistry Systems due to increased U90-382 or 6LU condition codes generated when using Calibrator Kit 9, Lot 954.

    Product
    VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs disc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1073-2016·2016-03-16

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Error Codes

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because they may generate specific error codes when used with a recalled Calibrator Kit 9 lot.

    Product
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of cli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2016·2016-03-02

    Siemens Mammomat Inspiration Recall for Potential System Fatal Error

    Siemens is recalling 76 Mammomat Inspiration units because a system fatal error may occur during tomosynthesis reconstruction for large breasts, causing the process to abort.

    Product
    Mammomat Inspiration with Tomosynthesis functionality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0805-2016·2016-02-24

    Varian Eclipse Treatment Planning System Recall for Dose Calculation Error

    Varian Medical Systems is recalling Eclipse Treatment Planning System versions 11, 13.0, 13.5, and 13.6 due to a dose calculation error that may result in unintended radiation exposure.

    Product
    Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan exter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0752-2016·2016-02-17

    Toshiba INFX-8000V X-Ray System Recalled for Dose Meter Error

    Toshiba is recalling four INFX-8000V Bi-Plane X-Ray Interventional Systems because a software error caused dose data to be lost during specific imaging procedures.

    Product
    INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0692-2016·2016-02-10

    Draeger Oxylog 3000 Ventilators Recalled for Software Error

    Draeger Medical is recalling Oxylog 3000 and Oxylog 3000 Plus ventilators because a software error can stop ventilation and trigger alarms.

    Product
    Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2016·2016-02-10

    Philips Allura Xper FD20 Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD20 systems because still images may be misinterpreted as live images, potentially affecting diagnostic accuracy.

    Product
    Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2016·2016-02-10

    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 V3000; Model Number: 72243, 72244, 72245 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 i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0715-2016·2016-02-10

    Philips Allura Medical Imaging Systems Recalled for Image Interpretation Error

    Philips is recalling Allura CV20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.

    Product
    Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2016·2016-02-10

    Philips Allura Xper Biplane OR Table Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD20 Biplane OR Tables because still images may be incorrectly interpreted as live images during use.

    Product
    Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0713-2016·2016-02-10

    Philips Allura Xper FD20/20 Recall for Image Interpretation Error

    Philips is recalling 13,297 Allura Xper FD20/20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.

    Product
    Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisat
    Category
    Medical Device
    Distribution
    Distributed nationwide