—#70899

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.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K063283
Affected lot / code info: Model Number 5220493: PC0127XR06, M1973721

Why it was recalled

GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.

Timeline

Recall initiated: 2007-12-17
Posted by FDA: 2008-09-04
Terminated: 2008-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70899. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.