Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-1133-2008
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 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
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.
-
-