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.

1176–1200 of 1375

  • ModerateFDA (Devices)·Z-0773-2014·2014-01-22

    GE Healthcare Recalls Imagecast PACS Software Due to Measurement Errors

    GE Healthcare is recalling Imagecast PACS versions prior to 3.6.51.01 because the software fails to account for the estimated magnification factor, leading to inaccurate distance measurements.

    Product
    Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13E073000·2013-12-20

    GM Recalls 2014 Trucks for Transmission Software Error

    General Motors is recalling 2014 Chevrolet Silverados and GMC Sierras because incorrect transmission software may fail to display first gear, increasing crash risk.

    Product
    GMC — GMC, CHEVROLET SIERRA, SILVERADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2014·2013-12-18

    IBA COMPASS Software Recall for Erroneous Dose Statistics

    IBA Dosimetry GmbH is recalling COMPASS SW Version 3.0 due to a software defect that causes erroneous dose statistics and DVHs.

    Product
    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0469-2014·2013-12-18

    Omnyx Digital Pathology Software Recalled for Incorrect Measurement Display

    Omnyx LLC is recalling Digital Pathology System (DPS) Software version 1.1 because its annotation tools may display incorrect measurements and area calculations for regions of interest on scanned slides.

    Product
    Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0433-2014·2013-12-11

    Siemens syngo Lab Data Manager Software Recall for Auto-verification Failures

    Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager software versions VA11B and VA12A because the system may release results that require manual review or delay result transmission.

    Product
    syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0439-2014·2013-12-11

    Varian Medical Systems Recalls C-Series Linear Accelerators for Software Correction

    Varian Medical Systems is recalling 3,809 C-Series linear accelerators to install a software solution that corrects a previous issue.

    Product
    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2014·2013-12-04

    Siemens Fluoroscopic X-Ray Systems Recalled for Radiation Malfunction

    Siemens is recalling specific fluoroscopic x-ray systems due to a software defect that may cause radiation to continue longer than required, resulting in overexposed images.

    Product
    (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2014·2013-11-27

    Siemens ADVIA 1200 Software Recalled for Ration Parameter Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1200 System Software versions 2.00 and 2.01 due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Parameter Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1800 System Software V2.01 due to ration parameters flagging behavior issues.

    Product
    ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0330-2014·2013-11-27

    GE Centricity Laboratory Software Recalled for Panel Reflex Failure

    GE Healthcare is recalling Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because panel reflexing may fail under specific conditions.

    Product
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1650 system software due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0346-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 2400 System Software V4.01 due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0337-2014·2013-11-27

    GE Healthcare Recalls Centricity Perinatal and Intensive Care Software

    GE Healthcare is recalling Centricity Perinatal and Intensive Care software due to a rare network issue that may temporarily prevent users from accessing patient rosters.

    Product
    Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0231-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0242-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0270-2014·2013-11-20

    GE Healthcare Recalls AW Workstations Due to Image Orientation Error

    GE Healthcare is recalling AW VolumeShare and AW Server software due to a potential safety issue where images may display in the wrong orientation after rotation.

    Product
    AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0269-2014·2013-11-20

    Philips IntelliSpace PACS 4.4 Software Recall for Image Storage Defect

    Philips is recalling IntelliSpace PACS 4.4 software due to a timing issue that may prevent the system from storing additional images, potentially affecting clinical diagnoses.

    Product
    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0239-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0228-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading into the viewer under specific conditions.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0243-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0226-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0260-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because a defect may prevent some CT and MR images from loading in the viewer.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0225-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0245-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer under specific conditions.

    Product
    Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0227-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states