Home › Device types › MWI
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
FDA product code MWI · Class 2 · Cardiovascular
1,983
Registered devices
2,174
Adverse events
85
Recalls
308
510(k) clearances
Devices with this code
Welch Allyn, Inc. — WELCH ALLYN, INC.NeoBeat Charging Stand — Laerdal Medical ASNorav 1200 Series PC-ECG — NORAV MEDICAL LTD.Lutech — LUTECH INDUSTRIES INCPORTRAIT SpO2 P-SA01 — GE Healthcare Finland OyPatient Monitor — Guangdong Biolight Meditech Co., Ltd.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.SmartLinx Vitals Plus — Philips North America LLCSmartLinx Vitals Plus — Philips North America LLCSmartLinx Vitals Plus — Philips North America LLCWelch Allyn, Inc. — WELCH ALLYN, INC.N/A — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Lutech — LUTECH INDUSTRIES INCWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Capsule Vitals Plus — Philips North America LLCWelch Allyn, Inc. — WELCH ALLYN, INC.Nomoline — MASIMO CORPORATIONMR Patient Care Short Neonatal ECG 2.0 Cable AAMI — Philips Ds North America LLCWelch Allyn, Inc. — WELCH ALLYN, INC.MR Patient Care Short Wide ECG 2.0 Cable AAMI — Philips Ds North America LLCMRI ECG Cable — IVY BIOMEDICAL SYSTEMS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults foll |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults foll |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults foll |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults foll |
| 2026-07-10 | GE Medical Systems Information Technologies Inc | Portrait Core Services Software version V1.2.0 Security Vulnerability |
| 2026-01-30 | Covidien LLC | Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote |
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