—#70958

Product

GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2. 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 5220493-2: 0002695030, 904321DEF5, 480543XR1, 254965D5000, 601855D5K, 914864D5000, 614293D5KX, 239482D5000, 239432D5000, 0002697145, RADNETDEF1, and 239596D5000.

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 #70958. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.