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 Recall Z-1134-2008 · Posted 2008-09-04
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeKPR
Date Initiated2007-12-17
Date Terminated2008-09-10
Product Quantity14 devices (12US & 2 OUS)
Reason for Recall
GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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