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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Definium 5000 Digital Radiographic Imaging System.

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 Class 2 Device Recall GE Healthcare Definium 5000 Digital Radiographic Imaging System.see related information
Date Initiated by FirmDecember 17, 2007
Date PostedSeptember 04, 2008
Recall Status1 Terminated 3 on September 10, 2008
Recall NumberZ-1133-2008
Recall Event ID 48144
510(K)NumberK063283 
Product Classification Digital Radiographic Imaging System - Product Code KPR
ProductGE 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.
Code Information Model Number 5220493:  PC0127XR06, M1973721
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall		GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionA 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 Commerce14 devices (12US & 2 OUS)
DistributionMD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPR
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