Home › Device types › MWI
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
FDA product code MWI · Class 2 · Cardiovascular
1,939
Registered devices
1,983
Adverse events
81
Recalls
308
510(k) clearances
Devices with this code
Welch Allyn, Inc. — WELCH ALLYN, INC.Norav 1200 Series PC-ECG — NORAV MEDICAL LTD.SmartLinx Vitals Plus — Philips North America LLCWelch Allyn, Inc. — WELCH ALLYN, INC.MR Patient Care Neonatal ECG 3.0 Cable IEC — Philips Medizin Systeme Böblingen GmbHNorav 1200 Series PC-ECG — NORAV MEDICAL LTD.Welch Allyn, Inc. — WELCH ALLYN, INC.740 SELECT — ZOE MEDICAL INCORPORATEDIradimed — IRADIMED CORP.NA — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.Expression MRI Patient Monitoring System (Model 865214) — Philips Ds North America LLCSmartLinx Vitals Plus — Philips North America LLCMR Patient Care SpO2 Sensor — Philips Medizin Systeme Böblingen GmbHNorav 1200 Series PC-ECG — NORAV MEDICAL LTD.Norav 1200 Series PC-ECG — NORAV MEDICAL LTD.Cable, Digitial Gating, Hitachi / Toshiba — Philips Ds North America LLC740 SELECT — ZOE MEDICAL INCORPORATEDLutech — LUTECH INDUSTRIES INCCentral Hub CMS — Sibel Health Inc.Lutech — LUTECH INDUSTRIES INCCapsule Vitals Plus — Philips North America LLCCapsule Surveillance — Philips North America LLCNIBP Pressure cuff 9 - 15 cm — MIPM Mammendorfer Institut für Physik und Medizin GmbHJaeger — Jaeger Medical GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-05-22 | CHANGE HEALTHCARE CANADA COMPANY | Due to complaints, software update may cause software to unexpectedly shutdown. |
| 2025-05-22 | CHANGE HEALTHCARE CANADA COMPANY | Due to complaints, software update may cause software to unexpectedly shutdown. |
| 2025-03-24 | Baxter Healthcare Corporation | There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, |
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