Hazard

Software Crash recalls

14 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 14
Critical: 0
Severe: 1
Most recent: 2025-11-26

Of the 14 software crash recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (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 crash 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.

1–14 of 14

HighFDA (Devices)·Z-0541-2026·2025-11-26
Flow cytometers recalled over software that crashes during sample acquisition
Beckman Coulter is recalling 25 DxFLEX Flow Cytometers because a software error crashes the system during acquisition on a patient sample when running a customer defined protocol.
Product
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2440-2024·2024-07-31
Sensis Vibe Cardiac Imaging System Software May Crash During Documentation
Siemens' Sensis Vibe cardiac imaging system software may crash when documentation functionality is used during diagnostic event recording. Two affected systems have been recalled nationwide.
Product
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as intervention
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2438-2024·2024-07-31
Sensis Vibe diagnostic systems software crash during event documentation
Siemens Sensis Vibe diagnostic systems may crash when using documentation features during once-per-study event reporting. Three systems are affected; no injuries reported.
Product
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as wel
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2441-2024·2024-07-31
Sensis Vibe medical diagnostic system software crashes during documentation events
A software issue in certain Siemens Sensis Vibe diagnostic systems may cause the application to crash when documentation features are used during clinical reporting events.
Product
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2439-2024·2024-07-31
Medical device diagnostic software vulnerability causes potential application crashes
Siemens Sensis Vibe diagnostic systems may crash when documentation functionality is used during certain reporting events. Seven units were distributed to facilities nationwide.
Product
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0683-2024·2024-01-17
Sensis Vibe Hemo Medical Device Software May Crash
Siemens is recalling 331 units of the Sensis Vibe Hemo medical device due to a potential software crash in its documentation functionality application. Units affected are distributed in California, Connecticut, and Florida.
Product
Sensis Vibe Hemo
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0306-2024·2023-11-22
Philips Spectral CT on Rails Software Crash During Fluoroscopy Operations
Philips is recalling the Spectral CT on Rails (Model 728334, Software Version 5.1.0) due to a software crash that occurs when CCT Fluoroscopy mode and foot pedal are activated simultaneously. The crash requires system restart.
Product
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2608-2023·2023-09-27
Philips Patient Information Center iX Software Crashes Delay Patient Monitoring
Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.
Product
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essential
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0775-2023·2023-01-11
Programmable Diagnostic Computer Software Update Addresses Crash Errors
Siemens is updating software in 638 Programmable Diagnostic Computers distributed in the US to fix four software errors that could crash the device or corrupt password storage, potentially delaying diagnostics.
Product
Programmable Diagnostic Computer
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1763-2022·2022-10-05
TANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide
FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.
Product
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1881-2017·2017-05-03
Zimmer CAS Recalls Navitrack Knee Software Due to Calibration Crash
Zimmer CAS is recalling Navitrack System - OS Knee Universal software due to a calibration sequence crash. The recall affects 105 units distributed worldwide.
Product
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0665-2017·2016-12-07
Merge Healthcare Recalls Hemo Software Due to Potential Application Crashes
Merge Healthcare is recalling Merge Hemo software versions 9.10 through 9.40.2 because the application may crash during cardiac catheterization procedures.
Product
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIB
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1125-2015·2015-02-25
Alive ECG App 2.1.2 Recalled for Application Crashes
Alivecor is recalling Alive ECG App version 2.1.2 for iOS because the application crashes upon use.
Product
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Moni
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1831-2012·2012-06-27
Spacelabs Healthcare Recalls Pathfinder SL Holter Analyzer Software
Spacelabs Healthcare is recalling Pathfinder SL software due to crashes and incorrect QTc values. The software is used to analyze Holter monitor data.
Product
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used t
Category
Medical Device
Distribution
Distributed nationwide