Home › Device types › MHX
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FDA product code MHX · Class 2 · Cardiovascular
2,417
Registered devices
32,228
Adverse events
283
Recalls
427
510(k) clearances
Devices with this code
Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INCEquivital LifeMonitor — HIDALGO LIMITEDIBP Cable, BD PXXXX-1 DTX/Plus — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.NA — NIHON KOHDEN AMERICA, INC.N/A — NIHON KOHDEN CORPORATIONShp Exc M300 Masimo PWT — DRAEGER MEDICAL SYSTEMS, INC.FUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.Welch Allyn, Inc. — WELCH ALLYN, INC.Skin Temp Probe (Ped/Inf) — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.ADVANCED CENTRAL MONITORING STATION — ADVANCED INSTRUMENTATIONS, INC.BeneVision M22C Patient Monitor — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CARESCAPE B850 — GE Healthcare Finland OyBluPRO® — NIHON KOHDEN CORPORATIONNihon Kohden Life Scope G7 Bedside Monitoring System — NIHON KOHDEN CORPORATIONNA — NIHON KOHDEN CORPORATIONFUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.Tempus Pro — REMOTE DIAGNOSTIC TECHNOLOGIES LIMITEDS/W SUB VF7.2 Gateway — DRAEGER MEDICAL SYSTEMS, INC.SYST MODULE RK,BENEVIEW 8SLOTS — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.N/A — NIHON KOHDEN CORPORATIONNA — NIHON KOHDEN CORPORATIONSchiller IBP transducer connecting cable — Schiller AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-05 | Philips North America Llc | Potential 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 |
| 2026-06-04 | Spacelabs Healthcare, Inc. | Due to off-the-shelf display port component that has audio/video failures |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 |
| 2026-02-20 | Masimo Corporation | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on no |
| 2026-02-20 | Masimo Corporation | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on no |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.