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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901028 · UDI-DI 00732094119206

MWI Prescription

510(k) clearances

2,065

Adverse events (45 deaths)

Recalls

172

Facilities

Description

Welch Allyn Connex Integrated Wall System with BP Cuff and Cord Management System, Otoscope and Ophthalmoscope Heads Not Included, S ureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Radio Ready; 100-240 V, 50-60 Hz AC, IEC Plug Type-B

Recalls

Date	Firm	Reason
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21	Midmark Corporation	A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
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 following the update and
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 following the update and
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 following the update and
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 following the update and
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 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.