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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901066 · UDI-DI 00732094327137

MWI Prescription
10
510(k) clearances
2,174
Adverse events (46 deaths)
85
Recalls
174
Facilities

Description

CSAS 1.8.2 CONTINUOUS

Recalls

DateFirmReason
2026-08-21Midmark CorporationA performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21Midmark CorporationA performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21Midmark CorporationA performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21Midmark CorporationA performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-07-20GE Medical Systems Information Technologies IncSoftware 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 following the update and
2026-07-20GE Medical Systems Information Technologies IncSoftware 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 following the update and
2026-07-20GE Medical Systems Information Technologies IncSoftware 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 following the update and
2026-07-20GE Medical Systems Information Technologies IncSoftware 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 following the update and
2026-07-10GE Medical Systems Information Technologies IncA software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or acc
2026-01-30Covidien LLCDue to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring s

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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.