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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901143 · UDI-DI 00732094301564

MLO
10
510(k) clearances
23
Adverse events (2 deaths)
2
Recalls
31
Facilities

Description

HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Turnkey workstation with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer

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
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.