INC Class II WELCH ALLYN PROTOCOL

Company: WELCH ALLYN PROTOCOL, INC
Date of Enforcement Report: 9/12/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-1049-1
Acuity Central Monitoring Stations with software versions 4.03.00, 4.03.01,4.03.02, 4.03.03, 4.03.04, and 4.03.05 when connected to VHF/UHF telemetry units CODES: software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05

REASON:
Incorrect Visual Display

MANUFACTURER/RECALLING FIRM:
WELCH ALLYN PROTOCOL, INC. BEAVERTON, OR

RECALLED BY:
Manufacturer, by letter dated March 13, 2001 and May 28, 2001 and by telephone on June 18, 2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide and Netherlands, France, and Canada

QUANTITY:
198

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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