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.

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 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.

1276–1300 of 1375

  • HighFDA (Devices)·Z-1112-2013·2013-04-24

    Carefusion Recalls Alaris PC Unit 8015 Due to Bolus Programming Risk

    Carefusion is recalling 4,090 Alaris PC unit model 8015 devices with software version 9.12 due to potential data loss risks during bolus programming.

    Product
    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2013·2013-04-24

    Horiba ABX PENTRA 400 I.S.E. Module Recalled for Missing Linearity Flags

    Horiba Medical is recalling ABX PENTRA 400 I.S.E. Modules because the software lacks Linearity Limit Flags for I.S.E. assays, which may prevent users from detecting out-of-range values.

    Product
    HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2013·2013-04-17

    Siemens Medical Solutions Recalls Elekta MOSAIQ Software Due to Safety Risk

    Siemens Medical Solutions is recalling Elekta MOSAIQ Oncology Information System software versions below 2.41 due to a potential safety risk identified by the manufacturer.

    Product
    ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1068-2013·2013-04-17

    Toshiba CT System Recalled for Software Error in Low-Current Scans

    Toshiba American Medical Systems Inc. is recalling one CT scanner in Maryland due to a software defect that may trigger false error messages during low-current scans.

    Product
    Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1067-2013·2013-04-17

    Toshiba Aquilion 32/64 CT Systems Recalled for Software Display Error

    Toshiba American Medical Systems is recalling 23 Aquilion 32/64 CT scanners due to a software issue that may cause incorrect Dose Length Product values to display.

    Product
    TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1029-2013·2013-04-10

    Philips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks

    Philips is updating software on one Ingenuity TF PET/CT system in Ohio to fix issues that could cause inaccurate readings or pose risks to patients and staff.

    Product
    Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1043-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for linear accelerators to address multiple performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1044-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Performance Defects

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and safety issues that were not considered critical for immediate correction.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1038-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions to address performance defects and non-critical safety issues identified during final system testing.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE Impression TH, Part No. 7341410, Current R630; Product Usage: The…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1042-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i, Part No. 7341428, Current R610/R630; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1037-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Safety Defects

    Siemens is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1039-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recalled for Performance Defects

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.0, Part No. 8139839, Current R630; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1041-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.2, Part No. 10568431, Current R640; Product Usage: The intended use…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1040-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens is recalling COHERENCE RT Therapist software versions to address performance defects and safety issues identified during final system testing.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.1, Part No. 8147667, Current R640; Product Usage: The intended use…
    Category
    Medical Device
    Distribution
    0 states
  • 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…
    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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • 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-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