The Recall Desk

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.

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.

876–900 of 1335

  • ModerateFDA (Devices)·Z-2317-2016·2016-08-10

    Medtronic Navigation Recalls Fusion ENT Software Application

    Medtronic Navigation is voluntarily recalling 27 units of the Fusion ENT software application due to a field action involving Neurologica scanners.

    Product
    Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2314-2016·2016-08-10

    Medtronic Navigation Recalls StealthStation Software Applications

    Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2316-2016·2016-08-10

    Medtronic Navigation StealthStation Software Voluntary Field Action

    Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2016·2016-08-03

    Elekta Recalls MOSAIQ Oncology System Due to Potential Dosing Errors

    Elekta is recalling 383 units of the MOSAIQ Oncology Information System because a software issue may prevent order changes from saving, potentially resulting in incorrect chemotherapy doses.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2016·2016-07-27

    RayStation Radiation Therapy Software Recalled for Incorrect Biological Goal Evaluation

    RaySearch Laboratories is recalling RayStation radiation therapy software versions 3.0 through 5 due to incorrect biological clinical goal values for adapted plans.

    Product
    RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose dist
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2217-2016·2016-07-27

    Carestream Touch Ultrasound Recalled for Volume Measurement Software Error

    Carestream Health is recalling Touch Prime and Touch Prime XE ultrasound units because a software issue may cause anatomy volume measurements to be overestimated.

    Product
    Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2125-2016·2016-07-13

    Medtronic Recalls MyCareLink Patient Monitor Due to Data Transmission Failure

    Medtronic is recalling 262 MyCareLink Patient Monitors because a software update prevents implanted device data from reaching clinicians, despite appearing successful to patients.

    Product
    Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2064-2016·2016-07-06

    CareFusion Alaris System PC Unit Recall for Incorrect Patient Weight Data

    CareFusion 303, Inc. is recalling 69,693 Alaris System PC Units because the RESTORE feature may incorrectly populate patient weight for specific infusion modules.

    Product
    Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2016·2016-07-06

    Siemens Recalls SYNGO Breast Care Software Due to Display Issues

    Siemens is voluntarily recalling 29 units of SYNGO Breast Care software because patient information can obscure view markers and facility details are not shown by default.

    Product
    SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2043-2016·2016-06-29

    Fujifilm Synapse PACS Software Recall for Image Display Failure

    Fujifilm Medical Systems is recalling 27 units of Synapse PACS software versions 4.4.000 through 4.4.020 because the software fails to display medical images, showing an error message instead.

    Product
    Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation So
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-2039-2016·2016-06-29

    Leica Biosystems Recalls CytoVision Systems Due to Windows 7 Activation Issues

    Leica Biosystems Richmond Inc. is recalling 283 CytoVision Image Analysis and Capture Systems because the Windows 7 operating system is improperly activated, appearing unlicensed.

    Product
    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2016·2016-06-15

    Philips Healthcare Ingenuity Core128 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Ingenuity Core128 CT systems in the US due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1691-2016·2016-06-15

    Sedecal Mobile X-ray System Recalled for Software Defect

    Sedecal USA is recalling 145 mobile x-ray systems in the US due to a software defect that may apply adult exposure parameters to newborns.

    Product
    Sedecal SA Mobile Diagnost w DR x-ray system
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1714-2016·2016-06-15

    Philips Brilliance iCT CT System Software Defect Recall

    Philips Healthcare is recalling Brilliance iCT Computed Tomography X-Ray Systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1713-2016·2016-06-15

    Philips Brilliance 64 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Brilliance 64 CT systems in the US due to software defects causing incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1716-2016·2016-06-15

    Philips Healthcare Ingenuity Core CT System Software Defect Recall

    Philips Healthcare is recalling Ingenuity Core CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1715-2016·2016-06-15

    Philips Brilliance iCT SP CT System Recalled for Software Defects

    Philips Healthcare is recalling Brilliance iCT SP CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1914-2016·2016-06-15

    Ortho VITROS 5600 System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 systems due to a software defect that may cause sample aspiration errors, leading to inaccurate or contaminated test results.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2016·2016-06-15

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software timing anomaly that may cause the device to aspirate or dispense into unintended samples, potentially leading to erroneous or contaminated results.

    Product
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1717-2016·2016-06-15

    Philips Ingenuity CT System Recalled for Software Defects

    Philips Healthcare is recalling Ingenuity CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1719-2016·2016-06-15

    Philips CT System Recalled for Software Defects Affecting Scan Accuracy

    Philips Healthcare is recalling Ingenuity Elite CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1886-2016·2016-06-08

    Siemens Dimension Vista 1500 Lab System Software Defect Recall

    Siemens is recalling Dimension Vista 1500 systems due to a software defect that may cause the device to omit a rinse step, potentially leading to discrepant patient results.

    Product
    Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2016·2016-06-08

    Siemens Dimension Vista 500 Lab System Software Defect Recall

    Siemens recalls Dimension Vista 500 systems due to a software defect that may omit probe rinses, potentially causing discrepant patient results.

    Product
    Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures suc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2016·2016-06-08

    Elekta Monaco RTP System Recalled for Treatment Planning Error

    Elekta is recalling Monaco RTP System software versions 5.10.00 and higher because a specific export setting causes incorrect jaw positioning in radiation therapy plans.

    Product
    Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1873-2016·2016-06-08

    Philips Ingenuity Core CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 300 Ingenuity Core CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Core Computed Tomography X-ray Systems, Product Usage: 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
    Distributed nationwide