Z-1133-2008

GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definium 5000...

Name: Z-1133-2008 GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definium 5000...
Creator: GE Healthcare
Published: 2007-12-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-12-17 / Terminated

FDA source

GE Healthcare began a recall of GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definium 5000 System is designed to handle radiographic... on 2007-12-17. The reason FDA records is "GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1133-2008
Status: Terminated
Initiated: 2007-12-17
Posted: 2008-09-04
Terminated: 2008-09-10
Recalling firm: GE Healthcare
Product: GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration includes a choice of elevating or non-elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital detector that captures radiographic images in digital form, as well as an X-ray generator/power unit.
Product code: KPR System, X-Ray, Stationary
Reason for recall: GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
FDA root cause: Radiation Control for Health and Safety Act
Action: A consignee letter dated 12/12/07 was sent to consignees (Director or Manager of Radiological Imaging, Clinical Administrator). The letter stated that an installed collimator failed compliance testing because of a blaze sizing issue. A GE Field Engineer site visit was also conducted (FMI No. 10814 12/18/07) to implement the correction. Contact GE Healthcare at 1-262-544-3894.
Quantity in commerce: 14 devices (12US & 2 OUS)
Distribution: MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.
Product codes and lots: Model Number 5220493: PC0127XR06, M1973721

Product code KPR

K063283Class IIDefinium 5000 X-Ray SystemSedecal., Sa. / cleared 2006-11-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)