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.

1001–1025 of 1375

  • ModerateFDA (Devices)·Z-0227-2016·2015-11-11

    Barco Surgical Display Recalled for Loss of User Settings After Power Cycle

    Barco Inc. is recalling specific surgical display models because user settings are lost when the systems are powered off and back on.

    Product
    Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
    Category
    Medical Device
    Distribution
    11 states
  • LowFDA (Devices)·Z-0210-2016·2015-11-11

    Steris Recalls AMSCO Steam Sterilizers Due to Foot Pedal Software Issue

    Steris Corporation is recalling 32 AMSCO 400 and AMSCO C Small Steam Sterilizers because a software defect prevents the foot pedal from operating the door.

    Product
    AMSCO 400 and AMSCO C Small Steam Sterilizers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0181-2016·2015-11-04

    Elekta Monaco Radiation Treatment Planning Software Recalled for Dose Errors

    Elekta is recalling Monaco Radiation Treatment Planning software due to unintended updates to dose and MU values and incorrect bolus assignments.

    Product
    Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0170-2016·2015-11-04

    Varian ARIA Radiation Oncology Software Recall for Printing Anomaly

    Varian Medical Systems is recalling ARIA Radiation Oncology software versions 10, 11, 13.0, and 13.5 because admin instructions may fail to print or transmit.

    Product
    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0135-2016·2015-10-28

    Philips MRI Systems Recalled for Incorrect Cross-Reference Lines in Spine Imaging

    Philips Medical Systems is recalling specific MRI systems due to a software defect that may cause cross-reference lines to be positioned incorrectly in spine clinical workflows.

    Product
    All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the…
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0117-2016·2015-10-21

    Natus Neurology Recalls NicoletOne Software Due to Signal Obstruction

    Natus Neurology is recalling NicoletOne Software v5.94 because a persistent impedance check signal obscures EEG data, potentially affecting clinical monitoring.

    Product
    NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0112-2016·2015-10-14

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling Monaco Radiation Treatment Planning System software version 5.10.00 because it may calculate incorrect dose and MU values under specific conditions.

    Product
    Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0106-2016·2015-10-14

    Siemens Syngo RT Oncologist software update addresses safety issues

    Siemens Medical Solutions is updating Syngo RT Oncologist software versions 4.2 and 4.3 to fix safety and performance issues.

    Product
    Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0021-2016·2015-10-14

    Siemens SOMATOM Definition AS CT Scanner Software Recall

    Siemens Medical Solutions is recalling 113 SOMATOM Definition AS CT scanners to fix a software bug affecting visual warnings and image quality.

    Product
    SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0023-2016·2015-10-14

    GE Healthcare Recalls Centricity PACS IW Due to Missing Images

    GE Healthcare is recalling 921 Centricity PACS IW systems worldwide because images may be missing when a specific system parameter is set to a value greater than 1.

    Product
    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0005-2016·2015-10-14

    Toshiba Recalls Celesteion PET/CT Systems Due to Data Loss Risk

    Toshiba American Medical Systems is recalling one Celesteion PCA-9000A/2 PET/CT System in Nevada because a software defect may prevent raw data from being saved during specific scans.

    Product
    Celesteion PCA-9000A/2 PET/CT System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0002-2016·2015-10-07

    Biosense Webster Recalls Carto 3 EP Navigation System Due to Image Loss

    Biosense Webster is recalling the Carto 3 EP Navigation System because the ultrasound image may disappear during use, requiring a system restart.

    Product
    Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2809-2015·2015-09-30

    Beckman Coulter MicroScan LabPro Software Recall for Manual Editing Error

    Beckman Coulter is recalling MicroScan LabPro software versions 1.0 to 4.11 because it incorrectly allows manual editing of carbohydrate substrates during specific manual readings.

    Product
    MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2812-2015·2015-09-30

    Siemens Medical Solutions Recalls Linear Accelerator Systems Due to Collision Risk

    Siemens Medical Solutions is recalling 26 linear accelerator systems and associated software because a defect could cause automatic movement, posing a collision risk to patients.

    Product
    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2775-2015·2015-09-23

    Bayer Medrad Mark 7 Arterion Injection System Software Recall

    Bayer Healthcare is recalling 71 Medrad Mark 7 Arterion Injection Systems due to a software defect that removes purge enforcement, potentially affecting angiographic studies.

    Product
    Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2783-2015·2015-09-23

    Siemens ACUSON SC2000 Ultrasound System Recalled for Data Capture Error

    Siemens is recalling ACUSON SC2000 ultrasound systems because a software error prevents the capture of images or clips when patient names are registered with different capitalization.

    Product
    ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2742-2015·2015-09-16

    Terumo CDI 500 Blood Parameter Monitoring System Recalled for Inaccurate Readings

    Terumo is recalling 4,638 CDI 500 Blood Parameter Monitoring Systems worldwide due to inaccurate readings of vital blood parameters following a software upgrade to version 1.69.

    Product
    CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2734-2015·2015-09-09

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Exposed Knife Blade

    Intuitive Surgical is recalling 198 da Vinci Xi Surgical Systems because the Xi Stapler may have an exposed knife blade when used with P4 software.

    Product
    da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2721-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 36 Transonic Flow Probes due to programming errors that cause incorrect meter readings.

    Product
    Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2722-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect in EPROM

    Transonic Systems Inc is recalling a 6 mm Transonic Flow Probe due to a software defect causing incorrect meter readings.

    Product
    Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2720-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect in EPROM

    Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2544-2015·2015-09-09

    Ortho VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may reset user-configured parameters to defaults during installation.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD --- Ortho Clinical Diagnostics…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2725-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 3 mm Flow Probes due to a software defect that causes flow meters to display incorrect status messages.

    Product
    Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2724-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect in EPROM

    Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2729-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 6 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide