• Definium 5000 U Arm

Definium 5000 U Arm

Question Answer Accessories: Does it include compression bands? Awaiting Confirmation Accessories: Does it include handgrips? Awaiting Confirmation DICOM 3.0: Is it DICOM 3.0 compatible? Awaiting Confirmation DICOM 3.0: Export? Awaiting Confirmation DICOM 3.0: Import? Awaiting Confirmation DICOM 3.0: Work List?

Awaiting Confirmation General: Did the device perform according to manufacturer specifications just before dismantling? Yes General: Is the device mortgaged? No General: Are there any visual or non visual damages? Awaiting Confirmation General: Is the refurbishing process accomplished by the original manufacturer or its authorized agent?

Class 2 Device Recall GE Healthcare Definium 5000 Digital Radiographic Imaging System. Buy GE Healthcare 5237622-3 DEFINIUM 5000 SOFTWARE APPLICATIONS CD COLLECTOR at PartsSource. Largest Online marketplace for Medical Equipment Replacement Parts. This program instructs X-ray Technologists in theory and operation of the GE Definium 5000 system.

Awaiting Confirmation General: Is the device still installed? Awaiting Confirmation General: Are you the owner of the device? Awaiting Confirmation General: Power supply - phase Awaiting Confirmation General: Power supply - Volts range Awaiting Confirmation General: What is the estimated size of the needed package? Awaiting Confirmation General: Does the system include a printer?

Awaiting Confirmation General: Does the system include an mAS indicator? Awaiting Confirmation General: Did this equipment pass the American College of Radiology (ACR) accreditation?

Awaiting Confirmation Manuals & Documentation: Is there an operation manual? Awaiting Confirmation Manuals & Documentation: Are there purchasing documents of the device?

Awaiting Confirmation Manuals & Documentation: Does it have all labels according to manufacturer's specification? Awaiting Confirmation Manuals & Documentation: Is there a calibration and adjustment file? Awaiting Confirmation Manuals & Documentation: Is there a maintenance service logbook? Awaiting Confirmation Manuals & Documentation: Is there a log of repair parts? Awaiting Confirmation Service & Warranty: Is there a warranty period after installation?

No Service & Warranty: Can you provide service and application support for this Device? Awaiting Confirmation System: Digital? Awaiting Confirmation X-ray Tube: What is the manufacturing date of the X-ray tube? Awaiting Confirmation X-ray Tube: What is the installation date of the X-ray tube? Awaiting Confirmation X-ray Tube: What is the last date the X-ray tube was operated? Awaiting Confirmation.

Class 2 Device Recall GE Healthcare Definium 5000 Digital Radiographic Imaging System. Download windows vista home premium 32 bit italiano isotopes. 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. 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.