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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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