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.

901–925 of 1335

  • ModerateFDA (Devices)·Z-1875-2016·2016-06-08

    Philips Ingenuity CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 215 Ingenuity CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity 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
  • ModerateFDA (Devices)·Z-1874-2016·2016-06-08

    Philips Ingenuity Core 128 CT Systems Recalled for Drive Mapping Issue

    Philips Medical Systems is recalling 424 Ingenuity Core 128 CT systems because the system may not map the Varian drive after a user logout and login.

    Product
    Ingenuity Core 128 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
  • ModerateFDA (Devices)·Z-1813-2016·2016-06-01

    Volcano Cardiology Imaging Systems Recalled for Network Compatibility Reboot Issue

    Volcano Corporation is recalling specific cardiology imaging systems due to a software incompatibility that can cause unexpected reboots when encountering specific hospital network data.

    Product
    Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2016·2016-06-01

    Elekta iGUIDE System Software Recall for Radiotherapy Positioning Errors

    Elekta, Inc. is recalling 20 iGUIDE Systems due to a software issue that may allow pre-treatment imaging to be performed before the HexaPOD is in the correct position.

    Product
    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1624-2016·2016-05-18

    Hamilton G5 Ventilator Recalled for Suctioning Maneuver Software Defect

    Hamilton Medical is recalling 1,115 Hamilton G5 ventilators because the ventilation pattern may not continue as expected after a suctioning maneuver.

    Product
    Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1650-2016·2016-05-18

    Neusoft NeuViz 64 CT Scanner Software Icon Mismatch Recall

    Neusoft Medical Systems is recalling seven NeuViz 64 CT scanners due to a software defect where side decubitus icons did not match the patient position description.

    Product
    NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1601-2016·2016-05-11

    Siemens Syngo Dynamics PACS Software Recall for Workflow Error

    Siemens is recalling 84 units of Syngo Dynamics software due to a defect that may cause old measurements to be carried forward into new reports.

    Product
    Syngo Dynamics; Kinetdx Picture Archiving and Communications System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2016·2016-05-11

    Nuvectra Algovita Spinal Cord Stimulation Programmer Recall for Software Defect

    Nuvectra is recalling 17 Algovita Spinal Cord Stimulation System Clinical Programmers (Model 4500) because a software defect may prevent users from recharging the implantable pulse generator.

    Product
    Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1592-2016·2016-05-11

    Siemens ACUSON SC2000 Ultrasound System Recalled for Trackball Control Failure

    Siemens is recalling 87 ACUSON SC2000 ultrasound systems because the trackball may fail to control specific imaging parameters during transesophageal procedures.

    Product
    ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1605-2016·2016-05-11

    Medtronic CareLink Monitors Recalled for Firmware Dial-Up Configuration Error

    Medtronic is recalling CareLink and CareLink Express monitors because a firmware update contained incorrect dial-up configuration data, potentially preventing data transmission to the CareLink Network.

    Product
    Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLi
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1575-2016·2016-05-04

    Mindray Panorama Patient Monitoring Network Recalled for Date Reversion

    Mindray DS USA is recalling Panorama Patient Monitoring Network units that may revert to the year 2000 during Daylight Savings Time.

    Product
    Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·16V257000·2016-04-28

    GM Recalls 2013-2016 Chevrolet Vehicles for Theft Protection Software Defect

    General Motors is recalling certain 2013-2016 Chevrolet Sonic, Trax, and Spark vehicles because the radio software may fail to provide an audible warning chime, increasing the risk of vehicle theft.

    Product
    CHEVROLET — CHEVROLET TRAX, SPARK, SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2016·2016-04-27

    Siemens SOMATOM Definition Flash CT Systems Recalled for Software Bugs

    Siemens Medical Solutions is recalling 1,096 CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.

    Product
    Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2016·2016-04-27

    Siemens SOMATOM Definition CT Systems Recalled for Software Bugs

    Siemens Medical Solutions USA is recalling 1,096 SOMATOM Definition CT systems due to software bugs that may cause scan aborts, re-scans, or accidental radiation.

    Product
    Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1504-2016·2016-04-27

    Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

    Philips Medical Systems is recalling the AutoSPECT Pro software application because it may produce erroneous results when processing cardiac SPECT data acquired at detector angles other than 90 or 180 degrees.

    Product
    Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1519-2016·2016-04-27

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bugs

    Siemens is recalling 1,096 SOMATOM Definition AS CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.

    Product
    Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1500-2016·2016-04-27

    Siemens ADVIA 560 Hematology System Software Recall

    Siemens is recalling ADVIA 560 Hematology Systems because a software defect prevents the system from flagging immature granulocytes and atypical lymphocytes in patient samples.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1379-2016·2016-04-20

    Stryker SurgiCounter Scanner Recalled for Software Interaction Errors

    Stryker is recalling 286 SurgiCounter scanners because they may display error messages and fail to display software version numbers correctly in the SC360 application.

    Product
    SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1309-2016·2016-04-06

    ViewRay MRIdian Radiation Therapy System Software Recall

    ViewRay is recalling 5 MRIdian Radiation Therapy Systems due to a software defect that may fail to prompt users to shift the couch to a new isocenter during re-optimization.

    Product
    MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1308-2016·2016-04-06

    Mitsubishi VERO MHI-TM2000 Linear Accelerator Recall for Gantry Angle Error

    Mitsubishi Heavy Industries is recalling VERO MHI-TM2000 Linear Accelerators because the operator console may set an incorrect gantry angle for the first beam of an IMRT treatment.

    Product
    VERO MHI-TM2000 Linear Accelerator System --- 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
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2016·2016-04-06

    Siemens Recalls Cios Alpha Mobile X-Ray Systems Due to Software Issues

    Siemens Medical Solutions is recalling 89 Cios Alpha mobile X-ray systems due to software issues. The units were distributed nationwide to 30 states.

    Product
    Cios Alpha, mobile X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1249-2016·2016-04-06

    Medtronic Recalls Reveal LINQ Cardiac Monitor Due to Algorithm Sensitivity Issue

    Medtronic is recalling Reveal LINQ insertable cardiac monitors because an algorithm issue may trigger replacement alerts prematurely. The device battery and data collection capabilities remain functional.

    Product
    Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2016·2016-03-23

    McKesson Medical Imaging Software Recalled for Potential Image Display Errors

    McKesson is recalling Horizon Medical Imaging and Radiology software due to a design deficiency that may cause incorrect patient images to be displayed.

    Product
    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1183-2016·2016-03-23

    Siemens Syngo Dynamics PACS Software Recall for Measurement Package Issue

    Siemens is recalling Syngo Dynamics PACS software due to a potential issue in the VA10 measurement package. 228 units are affected nationwide.

    Product
    Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2016·2016-03-16

    Philips Respironics Recalls Trilogy and Garbin Ventilators Due to Software Issue

    Philips Respironics is recalling approximately 104,508 Trilogy and Garbin ventilators due to a software issue. The recall covers units distributed nationwide and internationally.

    Product
    Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide