Z-2563-2011

GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare...

Name: Z-2563-2011 GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare...
Creator: Ge Healthcare It
Published: 2011-05-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-05-03 / Terminated / root cause: software

FDA source

Ge Healthcare It began a recall of GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010. The Centricity... on 2011-05-03. The reason FDA records is "The GE Centricity Laboratory Instrument Interface to Data Innovations is processing a preliminary result instead of the final result from the Process System Manager when there is a test rerun conducted". 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-2563-2011
Status: Terminated
Initiated: 2011-05-03
Posted: 2011-06-14
Terminated: 2011-10-04
Recalling firm: GE Healthcare
Product: GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010. The Centricity Laboratory is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: The GE Centricity Laboratory Instrument Interface to Data Innovations is processing a preliminary result instead of the final result from the Process System Manager when there is a test rerun conducted.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 3, 2011 to all affected customers. The letter describes the product, problem, and action to be taken by the customer. The letter provided the users with specific safety instructions to follow until the software was updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.
Quantity in commerce: 14 units
Distribution: Worldwide Distribution-- USA (nationwide) including states of Georgia, New York, Ohio, Oregon, and Tennessee and countries of Canada, England, and Qatar.
Product codes and lots: Versions 3.3, 4.0 and 4.1

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)