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.

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.

976–1000 of 1335

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, Peripheral
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 Surgical
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2728-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 4 mm Flow Probes due to software defects causing incorrect meter readings.
Product
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2723-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 8 mm Flow Probes due to a software defect that causes flow meters to display incorrect error messages.
Product
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2727-2015·2015-09-09
Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 3 mm Flow Probes due to software defects causing incorrect readings on flow meters.
Product
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
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-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-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-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
ModerateFDA (Devices)·Z-2726-2015·2015-09-09
Transonic Flow Probe Recall 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 HQD2FMC -- 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-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-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 I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2470-2015·2015-09-02
GE Healthcare Recalls Centricity Universal Viewer Software Due to Image Loss
GE Healthcare is recalling 26 Centricity Universal Viewer Version 6.0 systems because medical images may be missing when a specific system parameter is set to a value greater than 1.
Product
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2383-2015·2015-09-02
Philips DigitalDiagnost X-ray Systems Recalled for Missing Exposure Beep Signal
Philips is recalling 62 DigitalDiagnost X-ray systems because a software defect prevents the exposure termination beep from sounding after 12 hours of operation.
Product
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2469-2015·2015-09-02
GE Healthcare Recalls Centricity PACS-IW Systems Due to Missing Images
GE Healthcare is recalling 82 Centricity PACS-IW systems because medical images may be missing when a specific system parameter is set to a value greater than 1.
Product
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2449-2015·2015-09-02
Carestream DRX-Evolution X-Ray System Recalled for Image Stitching Defect
Carestream Health is recalling DRX-Evolution X-ray systems due to a software defect that may cause undetected image stitching inconsistencies.
Product
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2404-2015·2015-08-26
Siemens Artis zee/zeego Systems Recalled for X-ray Locking Function Defect
Siemens Medical Solutions is recalling 586 Artis zee/zeego angiography systems because a system error could prevent users from exiting the X-ray locking function without a restart.
Product
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2015·2015-08-12
Philips HeartStart XL+ Defibrillator Recalled for Software and Hardware Issues
Philips is recalling 13,168 HeartStart XL+ defibrillators worldwide due to software and hardware issues that can affect device function.
Product
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2259-2015·2015-08-05
Philips Ingenuity CT Scanners Recalled for Software and Hardware Defects
Philips is recalling 159 Ingenuity CT scanners due to software errors affecting dose control, image artifacts, and heart rate measurement.
Product
Computed Tomography X-ray Systems Ingenuity CT scanners. 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
HighFDA (Devices)·Z-2255-2015·2015-08-05
Philips Brilliance iCT CT Systems Recalled for Software and Hardware Defects
Philips is recalling 38 Brilliance iCT CT systems due to software errors affecting dose control, heart rate measurement, and image artifacts.
Product
Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. 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
HighFDA (Devices)·Z-2257-2015·2015-08-05
Philips CT Systems Recalled for Software and Hardware Defects
Philips is recalling 82 Ingenuity Core CT systems due to software errors affecting image quality, dose control, and heart rate monitoring.
Product
Computed Tomography X-ray Systems Ingenuity Core. 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
HighFDA (Devices)·Z-2260-2015·2015-08-05
Medtronic MiniMed Recalls 620G and 640G Insulin Pumps for Bolus Screen Issue
Medtronic MiniMed is recalling 620G and 640G insulin pumps because the bolus screen may fail to timeout, displaying outdated dosing information.
Product
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2258-2015·2015-08-05
Philips CT Systems Recalled for Software and Hardware Defects
Philips is recalling 139 Ingenuity Core 128 CT scanners due to software errors affecting image quality, dose control, and heart rate monitoring.
Product
Computed Tomography X-ray Systems Ingenuity Core 128. 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