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.

1001–1025 of 1335

  • HighFDA (Devices)·Z-2256-2015·2015-08-05

    Philips Brilliance iCT SP CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling two Brilliance iCT SP CT systems due to software issues affecting image quality, dose control, and heart rate measurement.

    Product
    Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2254-2015·2015-08-05

    Philips Brilliance CT 64-Channel Systems Recalled for Software Defects

    Philips is recalling four Brilliance CT 64-channel systems due to software errors affecting image quality, dose control, and heart rate measurements.

    Product
    Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2195-2015·2015-07-29

    Philips Recalls GEMINI TF 16 Slice CT/PET Systems Due to Software Defects

    Philips is recalling 13 GEMINI TF 16 Slice CT/PET systems worldwide due to four software defects in the Tumor LOC application that may affect treatment accuracy.

    Product
    GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2196-2015·2015-07-29

    Philips GEMINI TF 64 Slice CT/PET System Software Defect Recall

    Philips is recalling 22 GEMINI TF 64 Slice CT/PET systems due to software defects that may cause incorrect tissue irradiation.

    Product
    GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2197-2015·2015-07-29

    Philips GEMINI TF Ready CT/PET System Software Defect Recall

    Philips is recalling GEMINI TF Ready CT/PET systems due to software defects that may cause incorrect radiation treatment.

    Product
    GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2136-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling specific software versions for its s5 and CORE Intravascular Ultrasound Systems because they may calculate inaccurate FFR/iFR values under certain circumstances.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2015·2015-07-29

    Philips Pinnacle3 Radiation Treatment Planning Software Recalled for Dose Inconsistency

    Philips is recalling Pinnacle3 Radiation Treatment Planning System software versions 8.0 and 9.0 due to potential dose inconsistencies with density-overridden ROIs.

    Product
    Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2134-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualita
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2015·2015-07-29

    Philips Recalls GEMINI TF Big Bore CT/PET Systems Due to Software Defects

    Philips is recalling 44 GEMINI TF Big Bore CT/PET systems worldwide because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.

    Product
    GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling Volcano s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2015·2015-07-29

    Philips Gemini GXL CT/PET System Software Recall for Tumor LOC Defects

    Philips is recalling two Gemini GXL 16 Slice CT/PET systems due to software defects in the Tumor LOC application that may cause incorrect tissue irradiation.

    Product
    GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5, s5i, and CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2063-2015·2015-07-22

    Elekta MOSAIQ Oncology Software Recalled for Incorrect Stereotactic Field Size

    Elekta is recalling MOSAIQ Oncology Information System software due to a defect that sends incorrect field sizes to treatment machines for stereotactic plans using cones.

    Product
    MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1954-2015·2015-07-08

    ViewRay Treatment Planning Software Recalled for Location Calculation Failure

    ViewRay is recalling Treatment Planning and Delivery System Software version 3.6 because it fails to determine new patient locations if imaging is not enabled.

    Product
    Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1969-2015·2015-07-08

    Tecan Infinite M1000 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite M1000 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2015·2015-07-08

    Varian VariSource iX Afterloader Systems Recalled for Calculation Errors

    Varian Medical Systems is recalling 55 VariSource iX afterloader systems because a software freeze can cause incorrect radiation dose calculations.

    Product
    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherap
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1967-2015·2015-07-08

    Tecan Infinite F500 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite F500 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1942-2015·2015-07-08

    Siemens EasyLink Data Management System Recalled for Software Limitations

    Siemens Healthcare Diagnostics is recalling 1,355 units of the EasyLink Data Management System due to software issues affecting reference ranges and sample actions.

    Product
    EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1971-2015·2015-07-08

    Tecan Infinite 200 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1959-2015·2015-07-08

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Data Loss

    Siemens Medical Solutions USA is recalling 573 ACUSON SC2000 ultrasound systems because specific keystrokes during 2D Stress Echo studies may cause selected clips to not be saved.

    Product
    ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1957-2015·2015-07-08

    Siemens CentraLink Data Management System Software Recall

    Siemens recalls CentraLink software because the sample query function may fail to return all samples from Dimension Vista systems under specific configurations.

    Product
    CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1970-2015·2015-07-08

    Tecan Infinite 200 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2015·2015-06-24

    CareFusion Alaris PC Unit Infusion Pump Software Recall

    CareFusion 303, Inc. is recalling 63 Alaris PC unit model 8015 infusion pumps due to a software defect that may allow infusions to start outside hospital-established limits.

    Product
    Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide