22
Aug
2001

Inc.ClassII Sunquest Information Systems

0

Company: SUNQUEST INFORMATION SYSTEMS, INC
Date of Enforcement Report
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0735-1, FlexiLab Laboratory Information System, Version 5.23

REASON:
Software anomaly

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-L18, June 8, 2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide and DENMARK.

QUANTITY:
82

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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