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Welch Allyn, Inc.
WELCH ALLYN, INC. · Model 901137 · UDI-DI 00732094319064
10
510(k) clearances
879
Adverse events (35 deaths)
98
Recalls
180
Facilities
Description
SCS w/ S4 Wifi telemetry & S12/S19 bedside moning; EN language CD manual; CPU(SCNODE config must be determined) w/ 110V pwr & dual color LCD 24" mons w/ high res; 8 telemetry channels (single display required); Loc storage 600 days, 110V HP LaserJet printer; VERITAS analysis algorithm w/ 12-lead ECG interp, ext arrhythmia, 12-lead ST segment mon, & hemodynamic calc(required for opw/ hard wired pat mon slots); Full disclosure & SC Interface; Protocol mgr, per channel
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | Midmark Corporation | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. |
| 2026-07-01 | Philips North America Llc | Device will intermittently provide inaccurate data related to native heart rate. |
| 2026-07-01 | Philips North America Llc | Device will intermittently provide inaccurate data related to native heart rate. |
| 2026-06-29 | GE Medical Systems Information Technologies Inc | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of |
| 2025-09-12 | Philips North America | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| 2025-09-12 | Philips North America | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| 2025-08-22 | GE Medical Systems, LLC | If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible |
| 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, after-market batter |
| 2024-12-18 | Braemar Manufacturing, LLC | Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring se |
| 2024-10-11 | Baxter Healthcare Corporation | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.