Aug

2001

Inc Class III Sunquest Information Systems

Company: SUNQUEST INFORMATION SYSTEMS, INC
Date of Enforcement Report: 8/22/01
Class: III

RECALL NUMBER, PRODUCT AND CODE:
Z-0733-1, FlexiLab Laboratory Information System Version 5.2, 5.23, and 5.3 interfaced with Anatomic Pathology Lab Access Transcription Workstation.

REASON:
Software glitch

MANUFACTURER/RECALLING FIRM:
SUNQUEST INFORMATION SYSTEMS, INC., TUCSON, AZ

RECALLED BY:
A temporary procedural workaround was communicated to all affected customers in Product Safety Notice, PSN-01-L12 on April 19th, May 16th, and May 23rd of 2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide & worldwide.

QUANTITY:
89 sites between 3 recalls

About the author

Amy Sellers

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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Inc Class III Sunquest Information Systems

Amy Sellers

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