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.

1076–1100 of 1375

  • ModerateFDA (Devices)·Z-1670-2015·2015-06-03

    Siemens Uroskop Omnia Max X-Ray System Software Data Loss Recall

    Siemens is recalling 133 Uroskop Omnia Max X-ray systems due to software defects that cause image deletion and connection issues.

    Product
    SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1646-2015·2015-06-03

    Siemens SOMATOM Perspective CT Scanner Software Recall

    Siemens is recalling 75 SOMATOM Perspective CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1554-2015·2015-05-27

    Philips DigitalDiagnost X-Ray System Recalled for Missing Exposure Beep Signal

    Philips Medical Systems is recalling 54 DigitalDiagnost X-Ray systems because they fail to emit a beep signal after exposure if powered on for over 12 hours.

    Product
    Philips Healthcare DigitalDiagnost System X-Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1574-2015·2015-05-13

    MHI-TM2000 Linear Accelerator System Software Recall for Communication Errors

    Mitsubishi Heavy Industries is recalling 11 MHI-TM2000 Linear Accelerator Systems due to a software defect that allows radiation delivery despite communication errors and prevents saving treatment records.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1582-2015·2015-05-13

    Brainlab ExacTrac 6.x Software Recalled for Potential Positioning Errors

    Brainlab AG is recalling ExacTrac 6.x software due to potential patient positioning errors when using CBCT at non-zero couch angles.

    Product
    ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1581-2015·2015-05-13

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Capture Failures

    Siemens is recalling 186 ACUSON SC2000 ultrasound systems because they may fail to capture images or clips during routine scans.

    Product
    ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1587-2015·2015-05-13

    Stryker Universal Battery Charger Recalled for Software Data Transmission Issue

    Stryker is recalling 223 Universal Battery Chargers because they are not transmitting usage data to the Stryker Cloud as designed. A software correction is being initiated.

    Product
    Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2015·2015-05-06

    Dako Omnis Software Module Recalled for Test Request Errors

    Dako North America is recalling the Test Request Distributor software module for the Dako Omnis System because it may execute the wrong test after a user updates a request.

    Product
    Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2015·2015-05-06

    Steris Recalls AMSCO Steam Sterilizers Due to Software Defect

    Steris is recalling 701 AMSCO C and AMSCO 400 steam sterilizers because a software defect may interrupt processing cycles, causing procedure delays.

    Product
    AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1451-2015·2015-04-22

    Baxter SIGMA Spectrum Infusion Pump Software Recall for Dose Display Discrepancy

    Baxter is recalling SIGMA Spectrum Infusion Pump software due to a discrepancy between Master Drug Library settings and pump display, which may cause therapy delays or unintended delivery rates.

    Product
    Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled…
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1399-2015·2015-04-15

    Siemens ADVIA Chemistry XPT Software Recall for Sample Processing Error

    Siemens is recalling ADVIA Chemistry XPT software version 1.0.2 because samples may remain in an 'Inprocess' state, preventing test results from transmitting to the Laboratory Information System.

    Product
    ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1369-2015·2015-04-08

    Roche Recalls Accu-Chek Connect App Due to Inaccurate Bolus Advice

    Roche Diabetes Care is recalling the Accu-Chek Connect app because a screen orientation change may cause it to provide inaccurate bolus advice to users.

    Product
    ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1359-2015·2015-04-08

    Philips CT Systems Recalled for Inverted Scan Position Software Defect

    Philips is recalling 424 CT systems worldwide because a software defect inverts the sign of the longitudinal position for some scans.

    Product
    Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2015·2015-04-08

    Siemens Syngo.plaza PACS Recalled for Incomplete Archived Studies

    Siemens Medical Solutions is recalling four Syngo.plaza PACS units because they may leave partially archived studies unarchived during pre-fetch operations.

    Product
    Syngo.plaza. 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.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0984-2015·2015-03-25

    Siemens ARTISTE MV System Linear Accelerator Recalled for Software Issue

    Siemens is recalling three ARTISTE MV System linear accelerators due to a software issue that may cause a dark current phenomenon during specific cancer treatments.

    Product
    ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    3 states
  • 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…
    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…
    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…
    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…
    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…
    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…
    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