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. This program instructs X-ray Technologists in theory and operation of the GE Definium 5000 system.

Digihome Pvr 160 Manual Transfer. 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.

Automatic/manual collimation with cassette size sensing available for both the table and wall stand; Three field ionization chamber detector. Definium 5000.

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. Caeremoniale Episcoporum Pdf File on this page. 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.

The Proteus XR/a is a full-featured fixed radiography system designed to address almost any clinical need. Clarke Hess 828 Manual Lymphatic Drainage more. It’s designed to accommodate your imaging requirements—and your operating budget. With our DR Imaging Option, you can easily convert your Proteus XR/a analog system to digital, thanks to FlashPad*, our next-generation wireless digital detector. If not today, here are reasons to go digital when you’re ready: • Convert to digital in as little as one day; with minimal downtime or interruption • Help support productivity through digital workflow • Maximize your investment by sharing FlashPad with compatible GE x-ray systems. The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. It can help expand your x-ray potential through digital upgrades and product configuration options.