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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 Firm December 17, 2007
Date Posted September 04, 2008
Recall Status1 Terminated 3 on September 10, 2008
Recall Number Z-1134-2008
Recall Event ID 48144
510(K)Number K063283  
Product Classification Digital Radiographic Imaging System - Product Code KPR
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.
Code Information Model Number 5220493-2:  0002695030, 904321DEF5, 480543XR1, 254965D5000, 601855D5K, 914864D5000, 614293D5KX, 239482D5000, 239432D5000, 0002697145, RADNETDEF1, and 239596D5000.
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
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.
Quantity in Commerce 14 devices (12US & 2 OUS)
Distribution MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KPR and Original Applicant = SEDECAL S.A.
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