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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901051 · UDI-DI 00732094046847

BZG Prescription
10
510(k) clearances
31
Adverse events
1
Recalls
93
Facilities

Description

Welch Allyn SpiroPerfect Spirometry Module includes SpiroPerfect Sensor, Pressure Tubing, Flow Transducers (Qty. 8), Training Posters (Qty. 2), and CardioPerfect Workstation Software

Recalls

DateFirmReason
2024-10-11Baxter Healthcare CorporationThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System

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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.