Class IIOngoingZ-0864-2026
Philips North America LLC recalls IntelliVue Patient Monitor MX500. Product Number: 866064.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 49 recalls
Class IIOngoingZ-0457-2026
GE Healthcare Finland Oy recalls BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Mode…
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power.…
GE Healthcare Finland…Nov 19, 2025
Class IIOngoingZ-0456-2026
GE Healthcare Finland Oy recalls Portrait VSM Model nos. 6660000-666 Monitor
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power.…
GE Healthcare Finland…Nov 19, 2025
Class IIOngoingZ-0455-2026
GE Healthcare Finland Oy recalls B105P
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power.…
GE Healthcare Finland…Nov 19, 2025
Class IIOngoingZ-0454-2026
GE Healthcare Finland Oy recalls CARESCAPE ONE
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power.…
GE Healthcare Finland…Nov 19, 2025
Class IIOngoingZ-0453-2026
GE Healthcare Finland Oy recalls Carescape B450
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power.…
GE Healthcare Finland…Nov 19, 2025
Class IIOngoingZ-0169-2026
Spacelabs Healthcare, Inc. recalls Brand Name: Branding is not applied to this product. Product Name: DVI display cables…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of anot…
Spacelabs Healthcare,…WAOct 22, 2025
Class IIOngoingZ-0168-2026
Spacelabs Healthcare, Inc. recalls Brand Name: Branding is not applied to this product. Product Name: DVI display cables…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of anot…
Spacelabs Healthcare,…WAOct 22, 2025
Class IIOngoingZ-0167-2026
Spacelabs Healthcare, Inc. recalls Brand Name: Branding is not applied to this product. Product Name: DVI display cables…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of anot…
Spacelabs Healthcare,…WAOct 22, 2025
Class IIOngoingZ-2672-2025
Schiller, Ag recalls Argus PB-3000
Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.
Schiller, AgOct 8, 2025
Class IIOngoingZ-2622-2025
Mindray DS USA, Inc. Dba Mindray North America recalls BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017
Potential for activation of an abnormal alarm pause.
Mindray DS USA, Inc. d…NJOct 1, 2025
Class IIOngoingZ-2175-2025
Remote Diagnostic Technologies Ltd. recalls Inseego USB8 4G Dongle Kit
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to…
Remote Diagnostic Tech…Aug 6, 2025