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.

1251–1275 of 1335

  • HighFDA (Devices)·Z-1002-2013·2013-04-03

    Vital Images Recalls Vitrea Software Due to Measurement Errors

    Vital Images is recalling Vitrea software versions prior to 6.3.3 due to a potential error in measurements generated when images are rotated during reconstruction.

    Product
    Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of mult
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0997-2013·2013-04-03

    Siemens Artis Angiographic X-Ray Systems Recalled for Image Registration Issues

    Siemens is recalling 81 Artis angiographic x-ray systems because a software issue may cause imprecise image registration during specific procedures.

    Product
    Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2013·2013-03-20

    Hill-Rom TotalCare SpO2RT2 Bed Recalled for Software Pressure Issue

    Hill-Rom is recalling 309 TotalCare SpO2RT2 beds due to a software defect that may reduce surface cushion pressure, potentially increasing the risk of skin irritation for high-risk patients.

    Product
    TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2013·2013-03-20

    Elekta Synergy XVI Radiation Therapy Imager Recalled for DICOM Tag Defect

    Elekta, Inc. is recalling 164 Synergy XVI Radiation Therapy Digital Imagers because DICOM tags lack sufficient information to identify volumes with the same name.

    Product
    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2013·2013-03-13

    GE Healthcare Recalls Advantage Workstation Volume Viewer Software

    GE Healthcare is recalling Advantage Workstation Volume Viewer software due to potential safety issues that may result in incorrect views and measurements.

    Product
    GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast,
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0907-2013·2013-03-13

    Siemens ARTISTE syngo RT Therapist software recall for beam delivery error

    Siemens is recalling 5 ARTISTE digital linear accelerators due to a software defect that may cause repeated delivery of radiation beams.

    Product
    SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0913-2013·2013-03-13

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall

    Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software data storage limitation that may prevent saving of certain sample results.

    Product
    Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0877-2013·2013-03-06

    Intel-GE Care Innovations Recalls QuietCare Facility Servers for Software Defect

    Intel-GE Care Innovations is recalling 19 QuietCare Facility Servers due to a software defect that may prevent Wander Alerts from being generated.

    Product
    QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0761-2013·2013-03-06

    GE Healthcare Recalls Brivo XR385 X-Ray Systems Due to Software Issue

    GE Healthcare is recalling nine Brivo XR385 X-Ray systems in the US due to a software issue affecting visual indications required by regulations.

    Product
    GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0884-2013·2013-03-06

    Philips DigitalDiagnost X-Ray System Recalled for Image Rotation Errors

    Philips Healthcare Inc. is recalling 551 DigitalDiagnost X-Ray Systems because images may rotate in the wrong direction, causing electronic side markers to be placed incorrectly.

    Product
    Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0841-2013·2013-02-27

    Elekta Monaco RTP System Recalled for Beam Angle Calculation Error

    Elekta is recalling 13 Monaco RTP Systems because the beam is displayed at the gantry angle, but the dose is calculated at the rotation_start angle.

    Product
    Monaco RTP System. Radiation treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2013·2013-02-27

    Varian Eclipse Treatment Planning System Recalled for Dose Calculation Error

    Varian Medical Systems is recalling 1,168 units of the Eclipse Treatment Planning System because the Pencil Beam Convolution 11.0 algorithm incorrectly calculates dose for dynamic plans with different energy fields.

    Product
    Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2013·2013-02-20

    Mindray DPM Central Monitoring System Recalled for ECG Waveform Anomaly

    Mindray is recalling 51 DPM Central Monitoring Systems because a software anomaly may display a step pattern instead of a flat line during asystole.

    Product
    Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2013·2013-02-20

    Terumo CDI 101 Hematocrit Monitor Recalled for Inaccurate Readings

    Terumo is recalling 622 CDI 101 Hematocrit/Oxygen Saturation Monitoring Systems because software errors cause inaccurate readings of blood and oxygen levels.

    Product
    Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0741-2013·2013-02-06

    Hamilton T1 Ventilator Recall for Pediatric Software Calculation Error

    Hamilton Medical Inc is recalling 97 Hamilton T1 ventilators with software versions 1.1.2 or lower due to a calculation error affecting oxygen consumption estimates for small pediatric patients.

    Product
    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0675-2013·2013-01-23

    Philips CT System Software Recall for Coronary Artery Labeling Defect

    Philips is recalling 108 CT systems because a software defect prevents users from labeling coronary arteries in rendered images.

    Product
    Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by c
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0634-2013·2013-01-09

    Abbott m2000sp Instrument Software Recall for Data Saving Error

    Abbott Molecular is recalling m2000sp Instruments due to a software issue where changes to control or calibrator information are not saved.

    Product
    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0479-2013·2013-01-02

    Philips CT System Software Update Addresses Nonhazardous Reliability Issues

    Philips is updating Extended Brilliance Workspace software to version 4.5.5 to fix nonhazardous reliability issues and improve system functionality.

    Product
    Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2013·2012-12-26

    Varian ARIA Radiation Oncology System Recall for DICOM Export Anomaly

    Varian Medical Systems is recalling ARIA Oncology Information System units due to a software anomaly where 360-degree arc fields may convert to static fields during DICOM import or export.

    Product
    Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured an
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0560-2013·2012-12-26

    GE Healthcare Recalls Advantage Workstation Software Due to Vessel Label Mismatch

    GE Healthcare is recalling specific Advantage Workstation software versions due to a potential vessel label mismatch and a measurement tool refresh issue that may impact patient safety.

    Product
    Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0524-2013·2012-12-26

    GE Healthcare Recalls Carescape Patient Data Module Software

    GE Healthcare is recalling Carescape Patient Data Module units with v2.0 software due to two issues that may impact patient care.

    Product
    GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and
    Category
    Medical Device
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-0492-2013·2012-12-19

    Roche DataCara GM Software Recalled for Diagnostic Issue

    Roche Molecular Systems is recalling DataCara GM software due to a device-associated diagnostic issue. 479 units were distributed nationwide.

    Product
    DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0485-2013·2012-12-19

    Roche MagNA Pure LC Software Recall for Diagnostic Issue

    Roche Molecular Systems is recalling 816 MagNA Pure LC instruments due to a device-associated diagnostic software issue.

    Product
    The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0491-2013·2012-12-19

    Roche DataInnovations Instrument Manager Software Recalled for Diagnostic Issue

    Roche Molecular Systems is recalling DataInnovations Instrument Manager software due to a device-associated diagnostic software issue.

    Product
    DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide