Hazard

System Malfunction recalls

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

What the numbers show

Total: 13
Critical: 0
Severe: 0
Most recent: 2025-07-02

Of the 13 system malfunction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 system malfunction 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.

1–13 of 13

HighFDA (Devices)·Z-1994-2025·2025-07-02
Barco NexxisOR System Display Encoders and Decoders Recalled
Barco N.V. is recalling certain NexxisOR system display encoder and decoder models due to duplicate MAC addresses that can cause system malfunction, audio/video interruptions, and delayed procedures when multiple units are deployed together.
Product
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; comp
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2025·2025-01-29
CardioMEMS HF Pressure Measurement System Recalled for Inaccurate Readings
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3214-2024·2024-10-02
GE Centricity PACS Image Storage Failure When Maximum Identifiers Reached
GE Healthcare Centricity PACS versions V2-V7 may fail to store medical images when reaching maximum unique image identifiers, potentially resulting in incomplete imaging studies. No injuries have been reported.
Product
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Category
Medical Device
Distribution
0 states
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-1177-2024·2024-02-28
Azurion 5 X-Ray System Generator May Fail Due to Circuit Short
Philips Azurion 5 X-ray systems with Certeray generators may experience power loss due to a potential short circuit in the power inverter board, potentially delaying or interrupting medical procedures.
Product
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0280-2024·2024-02-07
IV Phenylephrine Bags Recalled Due to Potential Double-Dose Delivery System Malfunction
Denver Solutions is recalling 12,564 bags of PHENYLephrine HCl IV solution nationwide due to a semi-automated filling system malfunction that could dispense double doses to patients.
Product
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2023·2023-04-26
Laboratory diagnostic device software issue may delay clinical diagnosis
BD Kiestra InoqulA+ (software versions 5.1/5.1.1) fails to display plate information after processing in clinical laboratories, risking diagnostic delays or specimen recollection.
Product
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1306-2022·2022-07-06
NaviCare Nurse Call System Cancels Patient Calls During Wireless Use
The NaviCare Nurse Call system software (versions 3.9.100-3.9.300) has a wireless integration defect causing patient calls to be canceled when answered on wireless phones. The issue affects 283 installations in the US and Canada.
Product
NaviCare Nurse Call/Voalte Nurse Call
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1289-2022·2022-07-06
Alphenix 4D CT system may stop operating due to system error
The Alphenix 4D CT system may fail to operate due to a system error that activates an interlock restriction. Six affected systems were distributed to hospitals in five U.S. states.
Product
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0123-2022·2021-10-27
Philips EPIQ CVxi Ultrasound Systems Software Issue Causes System Unresponsiveness
Philips EPIQ CVxi ultrasound systems running software versions 6.0, 7.0, or 7.0.3 may become unresponsive due to an EchoNavigator error, requiring system restart that could delay treatment.
Product
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-0275-2019·2018-10-31
Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.
Product
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D an
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2703-2017·2017-07-19
GE Healthcare Recalls Carestation Monitors for Potential Malfunction
GE Healthcare is recalling Carestation 620, 650, and 650c monitors due to potential for elevated FiCO2 readings and unexpected system malfunctions.
Product
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-0755-2017·2016-12-21
GE Healthcare Recalls Avance and Amingo Anesthesia Devices Due to Malfunction Risk
GE Healthcare is recalling specific Avance CS2, Avance, and Amingo anesthesia devices because they may enter a System Malfunction state if a storage drawer closes with excessive force.
Product
GE Healthcare, Avance, Avance CS2, Amingo.
Category
Medical Device
Distribution
Distributed nationwide