The Recall Desk

Hazard

Software Malfunction recalls

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

What the numbers show

Total
140
Critical
0
Severe
12
Most recent
2026-06-17

Of the 140 software malfunction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (9%) 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 malfunction 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.

126–140 of 140

  • HighFDA (Devices)·Z-0101-2018·2017-11-22

    ICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction

    ICU Medical is recalling 21,461 Plum 360 Infusion Systems because a software defect can prevent users from stopping the pump or restarting delivery under specific conditions.

    Product
    Plum 360 Infusion System, List number 30010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3076-2017·2017-09-06

    BioMérieux Recalls VITEK 2 Compact 30 Software and Reagent Cards

    BioMérieux is recalling VITEK 2 Compact 30 software and reagent cards because a software update prevents test cards from finalizing results, potentially disrupting laboratory processing.

    Product
    VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1457-2017·2017-03-22

    Merge Hemo software recalled due to study tab locking issue

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the system may incorrectly lock study tabs, potentially preventing access to data.

    Product
    Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0902-2017·2017-01-04

    PerkinElmer Recalls Specimen Gate Laboratory Software Due to Disk Space Issue

    PerkinElmer Health Sciences is recalling 21 units of Specimen Gate Laboratory and eReports software because a defect may cause excessive disk space consumption, leading to software failure.

    Product
    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module o
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0754-2017·2016-12-21

    Olympus HF Cable WA00014A Recalled for Software Malfunction

    Olympus Corporation of the Americas is recalling 494 HF Cable WA00014A units due to a software malfunction that may cause incorrect error codes to be generated or displayed.

    Product
    HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2639-2016·2016-08-31

    Ziehm Vision RFD 3D Mobile C-arm Recalled for Timer Malfunction

    Ziehm Imaging Inc is recalling 31 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1638-2016·2016-05-18

    Ascom Mobile Monitoring Gateway and Nurse Call Software Recall

    Ascom US, INC. is recalling 319 units of Mobile Monitoring Gateway and Unite Connect for Nurse Call due to a software malfunction that prevents automatic message forwarding if the primary module fails.

    Product
    Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-0451-2016·2015-12-30

    Shimadzu Mobile X-ray Systems Recalled for Image Transfer Issues

    Shimadzu Medical Systems is recalling 297 Mobile X-ray systems because images may not transfer properly to the image server.

    Product
    Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2111-2014·2014-07-30

    Siemens syngo Imaging XS Software Recall for Potential Miscalculation

    Siemens is recalling syngo Imaging XS software due to potential miscalculation of grey scale values in specific image processing functions.

    Product
    Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2014·2014-07-02

    Siemens RAD Fluoro Uro System Recalled for Image Malfunction

    Siemens is recalling 76 RAD Fluoro Uro Systems because a software malfunction can cause images to appear very dark, potentially leading to unnecessary repeat examinations.

    Product
    Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1668-2014·2014-06-04

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Software Malfunction

    Siemens is recalling 177 ACUSON SC2000 ultrasound systems due to a software issue in the Stress Echo feature that may require studies to be repeated.

    Product
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2318-2013·2013-10-09

    McKesson Horizon Medical Imaging System Recalled for Potential Image Loss

    McKesson Information Solutions LLC is recalling Horizon Medical Imaging software versions 4.6.1 to 11.6. because a server configuration malfunction may cause the loss of digital medical images.

    Product
    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medi
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0948-2013·2013-03-20

    Siemens CT Software Recall for Sporadic 3D Reconstruction Hang-Ups

    Siemens Medical Solutions is recalling 896 Somatom CT systems due to sporadic software malfunctions that cause 3D reconstructions to hang during preview.

    Product
    Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2264-2012·2012-09-05

    Siemens syngo Imaging XS Software Recall for Miscalculation Defect

    Siemens Medical Solutions is recalling 52 syngo Imaging XS systems due to potential miscalculation of grey scale values in specific image processing functions.

    Product
    syngo Imaging XS. Radiological image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2012·2012-08-01

    Siemens syngo.plaza Radiological Image Processing System Recalled for Malfunction

    Siemens is recalling two syngo.plaza radiological image processing systems due to a potential malfunction where images may fail to load without an error message.

    Product
    Siemens syngo.plaza. Radiological image processing system
    Category
    Medical Device
    Distribution
    Distributed nationwide