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.

1301–1325 of 1335

  • HighFDA (Devices)·Z-2255-2012·2012-09-19

    GE Healthcare Recalls Optima XR220amx Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling 254 Optima XR220amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.

    Product
    Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2012·2012-09-12

    Siemens syngo Lab Data Manager Recall for Quality Control Defect

    Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager and Process Manager software due to a defect that may prevent the system from flagging quality control violations appropriately.

    Product
    syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple inter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2012·2012-09-12

    Trek Diagnostic Systems Recalls VersaTREK Windows Software Version 5.4.3

    Trek Diagnostic Systems is recalling VersaTREK Windows Software Version 5.4.3 because positive test results may incorrectly revert to negative in the database.

    Product
    VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especial
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-2279-2012·2012-09-05

    Mindray Recalls V Series Patient Monitors Due to Software Anomalies

    Mindray is recalling 979 V Series Patient Monitors worldwide due to two identified software anomalies. No injuries have been reported.

    Product
    V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human ph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2012·2012-09-05

    Cisco HealthPresence Software Recall for Vital Signs Display Errors

    Cisco Systems is recalling HealthPresence software version 2.1 because subsequent vital signs readings may not update correctly in the OnePlace tab, potentially leading to incorrect interpretations.

    Product
    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco Heal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2278-2012·2012-09-05

    Toshiba MRI Systems Recalled for Sequence Queue Status Display Error

    Toshiba American Medical Systems is recalling 54 EXCELART MRI systems because the status display in the sequence queue window may fail to update from 'Current' to 'Done'.

    Product
    EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2223-2012·2012-08-29

    Philips CT Scanner Recall for Dose Limit Software Defect

    Philips is recalling eight Brilliance 64 and Ingenuity CT scanners because a software update allows users to disable dose alerts, potentially permitting scans that exceed safety limits.

    Product
    The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and displ
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2254-2012·2012-08-29

    Hitachi MRI Software Recall for Image Orientation Error

    Hitachi is recalling MRI software due to a defect that may reverse the orientation of the first image in a dataset.

    Product
    Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2238-2012·2012-08-29

    McKesson Horizon Medical Imaging System Recalled for Incorrect Report Status

    McKesson Medical Imaging Group is recalling Horizon Medical Imaging systems because reports may be saved with an incorrect final status.

    Product
    Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2012·2012-08-22

    GE Healthcare Advantage Workstations Recalled for Incorrect Aorta Measurements

    GE Healthcare is recalling Advantage Workstations with Advanced Vessel Analysis due to incorrect aorta measurements and potential issues with PET data loading.

    Product
    GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2012·2012-08-15

    Varian ARIA Oncology Software Recall Due to Incorrect MLC Data Import

    Varian Medical Systems is recalling two units of ARIA Oncology Information System software due to a defect that incorrectly imports MLC leaf positions for specific treatment plans.

    Product
    Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2156-2012·2012-08-15

    Philips MultiDiagnost Eleva X-ray System Recalled for 3D Reconstruction Failure

    Philips Healthcare Inc. is recalling 41 units of the MultiDiagnost Eleva X-ray system because the 3D reconstruction feature may fail to start during rotational angiography.

    Product
    Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2012·2012-08-08

    Smiths Medical Medfusion 4000 Syringe Infusion Pump Software Recall

    Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps due to a software anomaly that causes device history log corruption and triggers a Watchdog Fail-Safe alarm.

    Product
    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2068-2012·2012-08-01

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System Software due to a defect that prevents proper quality verification when reagent lots are switched.

    Product
    VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2012·2012-07-25

    Spacelabs Xprezzon Bedside Monitor Recalled for Display Disconnection

    Spacelabs Healthcare is recalling 21 Xprezzon Bedside Monitors because specific key presses can cause patient parameters to disappear from the display.

    Product
    Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1993-2012·2012-07-25

    GE Healthcare Recalls Optima Mobile X-ray Systems Due to Software Issue

    GE Healthcare is recalling Optima XR200 and XR220 mobile X-ray systems because a software issue affects the visual indication required by regulations.

    Product
    GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1960-2012·2012-07-18

    GE Healthcare Recalls CT/PET Fusion Software Due to Image Alignment Issues

    GE Healthcare is recalling CT/PET Fusion software versions 4.0, 4.1, and 4.2 because fused CT and PET images may be incorrectly aligned.

    Product
    GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2012·2012-07-18

    Philips HeartStart MRx Defibrillator Recalled for ECG Analysis Failure

    Philips is recalling 35 HeartStart MRx defibrillators because they cannot analyze ECG reports during 12-lead acquisition.

    Product
    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2007-2012·2012-07-18

    Elekta Monaco Software Recall for Incorrect Patient Shift Directions

    Elekta, Inc. is recalling Monaco radiation therapy planning software versions 3.10.00 through 3.20.00 due to a defect that prints incorrect patient shift directions when specific DICOM options are enabled.

    Product
    Monaco Product Usage: Planning of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2012·2012-07-18

    superDimension Systems Software Recall Due to Locatable Guide Malfunction

    superDimension, Inc. is recalling Systems with Software Version 4.0-4.9 because they fail to recognize the Locatable Guide.

    Product
    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1985-2012·2012-07-18

    GE OEC InstaTrak 3500 Plus Surgical Navigation System Software Recall

    GE OEC Medical Systems recalled 86 InstaTrak 3500 Plus surgical navigation systems due to software-related issues. The recall was initiated in 2006 but recently classified by the FDA due to administrative delays.

    Product
    InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2012·2012-07-18

    Philips Medical Systems Recalls IntelliSpace Portal and Extended Brillance Workspace Software

    Philips Medical Systems is recalling 38 units of IntelliSpace Portal and Extended Brillance Workspace software due to inconsistent diagnostic results when using specific time-based methods.

    Product
    IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1988-2012·2012-07-18

    Philips Recalls Intellispace Portal Software Due to Missing Warning Messages

    Philips is recalling 96 Intellispace Portal software units to fix a defect where the system fails to display a warning message when launching multiple patient studies.

    Product
    Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1791-2012·2012-06-20

    Philips Brilliance iCT and iCT SP CT Systems Software Update Recall

    Philips is issuing a software update for Brilliance iCT and iCT SP systems to address non-conformances that do not result in unacceptable hazards.

    Product
    The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment,
    Category
    Medical Device
    Distribution
    22 states
  • HighNHTSA·11E056000·2011-12-28

    Parker Hannifin Recalls New Flyer Transit Bus Instrument Panels

    Parker Hannifin is recalling instrument panels for New Flyer transit buses due to a software defect that may prevent warning messages from displaying, increasing crash risk.

    Product
    ELECTRICAL SYSTEM: INSTRUMENT CLUSTER/PANEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide