Class 2 Device Recall GE Healthcare Definium 5000 Digital Radiographic Imaging System. Date Initiated by Firm December 17, 2007 Date Posted September 04, 2008 Recall Status Terminated on September 10, 2008 Recall Number Z-1133-2008 Recall Event ID 510(K)Number Product Classification - Product Code 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 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 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 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. Senarai Program Asasi Usm Soar. 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. 510(K) Database.

GE Healthcare manufacturer specifications for Definium 5000 Rad Room, Digital on MedWOW medical equipment global marketplace. Used GE Definium 5000 Rad Room The. Scottish Games Carrollton Ky Detention. Definium™ 8000 helps you meet them. Definium is about getting the most done in the least amount of time. Thanks to impressive automated features. The Definium™ 5000 from GE Healthcare is the compact. Manual manipulation. GE Monogram and Definium are trademarks. The Definium™ 5000 from GE Healthcare is the compact. Manual manipulation. GE Monogram and Definium are trademarks.