Z-0472-2009

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

Name: Z-0472-2009 GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE...
Creator: GE Healthcare Integrated IT Solutions
Published: 2008-09-22
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-09-22 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL... on 2008-09-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0472-2009
Status: Terminated
Initiated: 2008-09-22
Posted: 2008-12-31
Terminated: 2010-05-18
Recalling firm: GE Healthcare
Product: GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 3 units
Distribution: Globally - United States including the states of New York and Texas; and the country of Canada.
Product codes and lots: Software versions 3.3.2.27_P4 and 4.0.1_SP.x

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)