FDA Recall Terminated

GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.

Recall: Z-0472-2009 · Initiated September 22, 2008

Recall

Recall Number
Z-0472-2009
Event Number
49517
Firm
GE Healthcare Integrated IT Solutions
FEI Number
3004526608
Product Code
JQP
Status
Terminated
Root Cause
Software design
Initiated
September 22, 2008
Posted
December 31, 2008
Terminated
May 18, 2010
Address
540 W Northwest Hwy, Barrington, IL, 60010-3051

Description

GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.

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. For further information, please telephone GE Healthcare Integrated IT Solutions at 800-437-1171.

Action

GE Healthcare notified their Centricity Ultra Laboratory Information System customers via letter dated 9/19/08. The letter was entitled "PRODUCT SAFETY NOTIFICATION." The letter states that the software correction was installed or will be installed to correct the abnormal results flag not being sent in the HL7 on results that are lower than the normal range. The letter summarized the safety concern and the action taken. Any questions were directed to GE Technical Support at 888-778-3373 or 905-479-1249. The accounts were requested to complete the enclosed customer reply form, supplying the software version number, and fax it back to 847-277-5240.

Distribution

Globally - United States including the states of New York and Texas; and the country of Canada.

Quantity

3 units