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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.