GE Healthcare 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. Recall
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According to the U.S. Food and Drug Administration (FDA)
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.
Brand
GE Healthcare
Lot Codes / Batch Numbers
Model Number 5220493: PC0127XR06, M1973721
Products Sold
Model Number 5220493: PC0127XR06, M1973721
GE Healthcare is recalling GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definium due to GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, MD, MS, NY, OH, TX
Page updated: Jan 10, 2026