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.

1301–1325 of 1375

  • 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
  • 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-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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    31 states
  • 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…
    Category
    Medical Device
    Distribution
    0 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-0490-2013·2012-12-19

    Roche Recalls COBAS INTEGRA 400 Analyzer Software Due to Diagnostic Issue

    Roche Molecular Systems is recalling 855 COBAS INTEGRA 400/400 plus systems due to a device-associated diagnostic software issue.

    Product
    The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
    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-0493-2013·2012-12-19

    Roche DataCare POC Software Recalled for Diagnostic Issue

    Roche Molecular Systems is recalling 126 units of DataCare POC software due to a device-associated diagnostic issue.

    Product
    DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0484-2013·2012-12-19

    Roche Data Station AMPLILINK Software Recalled for Device-Associated Issue

    Roche Molecular Systems is recalling Data Station AMPLILINK software due to a device-associated diagnostic software issue. The software is used with various COBAS instruments for molecular diagnostics.

    Product
    Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0486-2013·2012-12-19

    Roche MagNA Pure 96 System Software Recall

    Roche Molecular Systems is recalling 13 MagNA Pure 96 Systems due to a device-associated diagnostic software issue.

    Product
    The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • ModerateFDA (Devices)·Z-0489-2013·2012-12-19

    Roche COBAS 8000 Analyzer Software Recall for Diagnostic Issue

    Roche Molecular Systems is recalling 77 COBAS 8000 modular analyzers nationwide due to a device-associated diagnostic software issue.

    Product
    The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0487-2013·2012-12-19

    Roche LightCycler 1.2 Diagnostic Software Recalled for Device-Associated Issue

    Roche Molecular Systems is recalling LightCycler 1.2 software due to a device-associated diagnostic software issue. The recall covers 3,772 units distributed nationwide.

    Product
    LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0488-2013·2012-12-19

    Roche Recalls LightCycler 2.0 Instrument Due to Diagnostic Software Issue

    Roche Molecular Systems is recalling 1,213 LightCycler 2.0 instruments due to a device-associated diagnostic software issue.

    Product
    LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0513-2013·2012-12-19

    Mindray Recalls DPM 6 and 7 Patient Monitors for Software Limitations

    Mindray DS USA is recalling 124 DPM 6 and 7 patient monitors because specific calculation features may be unavailable.

    Product
    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2013·2012-12-12

    Siemens syngo.plaza Radiological Image Processing System Software Update Recall

    Siemens Medical Solutions USA, Inc. is recalling 15 syngo.plaza systems to address unintended software behavior that may affect system performance.

    Product
    Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2013·2012-12-05

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

    GE Healthcare is recalling Optima XR200amx and XR22Oamx mobile X-ray units due to a software issue on the interface.

    Product
    GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless…
    Category
    Medical Device
    Distribution
    Distributed nationwide