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Welch Allyn, Inc.
WELCH ALLYN, INC. · Model 901060 · UDI-DI 00732094088540
MWI
Prescription
10
510(k) clearances
2,065
Adverse events (45 deaths)
85
Recalls
172
Facilities
Description
Welch Allyn Connex 6500 Vital Signs Monitor with Nellcor SpO2, SureTemp Plus Thermometry, Internal Printer, Braun ThermoScan PRO 4000 Thermometry, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, BP Averaging, Nurse Call, Four USB Ports for Accessories, Internal 802.11 a/b/g Wireless Radio; 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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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.