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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901137 · UDI-DI 00732094262452

MHX

510(k) clearances

32,636

Adverse events (1,917 deaths)

286

Recalls

118

Facilities

Description

Surveyor Central Review Station - English language and CD manual; 220V power; Turnkey system includes configured CPU with DVD+/-RW drive; No printer; No display monitor; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export

Recalls

Date	Firm	Reason
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.
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 reconnect to the PI
2026-06-04	Spacelabs Healthcare, Inc.	Due to off-the-shelf display port component that has audio/video failures
2026-05-06	Criticare Technologies, Inc.	Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
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 and v6.0, can result
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 and v6.0, can result
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 and v6.0, can result
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 and v6.0, can result
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 and v6.0, can result

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Data 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.