Jan

2009

Cl Il GE Centricity Ultra Laboratory System SW

Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 1/7/2009
Class:ll

PRODUCT
GE Centricity Ultra Laboratory System Software for recording, reporting and distribution of lab results, Recall # Z-0472-2009

REASON
Software computer error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range.

RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated September 19, 2008.
Manufacturer: Triple G Systems Group, Inc., Markham, Canada. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3 units

DISTRIBUTION
Nationwide and Canada

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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Cl Il GE Centricity Ultra Laboratory System SW

Amy Sellers

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