Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FDA adverse event reports and recall history for monitor, physiological, patient(with arrhythmia detection or alarms) (product code MHX), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 33,126
- Deaths
- 1,928
- Injuries
- 3,739
- Malfunctions
- 27,181
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-10-07Open, ClassifiedLabeling design
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
BeneView Series. Operator's Manuals: T5 / T8
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-06Open, ClassifiedSoftware design
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Description: The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor. Component: No
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
- 2026-09-22Open, ClassifiedProcess design
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
- 2026-09-11Open, ClassifiedSoftware design
Philips Patient Information Center iX REF:866389
Due to software malfunction, patient information system may freeze and become unresponsive.
- 2026-09-11Open, ClassifiedSoftware design
Philips PIC iX Essentials REF:867093
Due to software malfunction, patient information system may freeze and become unresponsive.
Monitor monitor, physiological, patient(with arrhythmia detection or alarms) automatically
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