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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901138 · UDI-DI 00732094319804

MHX

510(k) clearances

32,636

Adverse events (1,917 deaths)

285

Recalls

118

Facilities

Description

Surveyor S19 GEN2 Pat Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, CO2, starter kit, resistive color touchscreen 18.5" display w/ 1366 x 768 res, AC or li-ion rechargeable battery operation; US/CA pwr cord; AHA 5 wire ECG pat cable with clip ends; Edwards invasive blood pressure cable (qty 2) and Y cable; No cardiac output cable; Ext thermal printer(w/ starter pack of thermal paper roll, 1.97 in. x 100 ft.,(50mm x 30.48m) 10 rolls); LAN; No mounting options

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
2026-04-24	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
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.