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Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

FDA product code MHX · Class 2 · Cardiovascular

2,467
Registered devices
33,126
Adverse events
293
Recalls
430
510(k) clearances

Devices with this code

Efficia CMS200 — Philips Medical Systems HsgSurveyor S12/S19 Patient Cable — MORTARA INSTRUMENT, INC.FUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.Prefense — Nihon Kohden Digital Health Solutions, LLCNA — NIHON KOHDEN AMERICA, INC.FUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.NetKonnect — Nihon Kohden Digital Health Solutions, LLCFUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.CUFF,DSNEO,CM1500C,5.8-10.9,20 (1ea=20p) — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.IntelliVue MP5 — Philips Medizin Systeme Böblingen GmbHTelemetry Accessories — Philips Medizin Systeme Böblingen GmbHPatient Information Center iX — Philips Medizin Systeme Böblingen GmbH5-LEAD,ECG,UNIV,SNAP,18",USA — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.N/A — NIHON KOHDEN CORPORATIONNA — GE Healthcare Finland OyNA — Nihon Kohden Digital Health Solutions, LLCFUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.UbiqVue — Lifesignals, Inc.NA — NIHON KOHDEN AMERICA, INC.ApexPro — GE Medical Systems Information Technologies, Inc.SureSigns VM1 — Philips Medical Systems HsgECG Cable, 20'(6.2 m), ESU-P, for N/T — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Welch Allyn, Inc. — WELCH ALLYN, INC.FUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.

Recent recalls

DateFirmReason
2026-09-08Nihon Kohden America LLCDue to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitor
2026-08-31Mindray DS USA, Inc.Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31Mindray DS USA, Inc.Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31Mindray DS USA, Inc.Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31Mindray DS USA, Inc.Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31Mindray DS USA, Inc.Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31Mindray DS USA, Inc.Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-07-31Philips North AmericaDue to software malfunction, patient information system may freeze and become unresponsive.
2026-07-31Philips North AmericaDue to software malfunction, patient information system may freeze and become unresponsive.
2026-06-05Philips North America LlcPotential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.