GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare

FDA device recall Z-0472-2009 · posted 2008-12-31 · Terminated

Recall details

Recalling firm

GE Healthcare Integrated IT Solutions

Reason for recall

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 taken

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

3 units

Distribution

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

Date initiated

2008-09-22

Date posted

2008-12-31

Date terminated

2010-05-18

Location

Barrington, IL