Safety Alert for Technical Name: Fixed X-ray Apparatus ANVISA Registration Number: 80071260010 Hazard Class: III Model Affected: Prestige II Serial Numbers Affected: PRESTIGE II X-RAY SYSTEM (Registration on ANVISA: 80071260010); PRESTIIX 1600 E X-RAY SYSTEM (Registration with ANVISA: 10310650033); X-RAY SYSTEM PRESTIGE SI AND PRESTIGE VH (Registration with ANVISA: 10310650014); X - LEGACY D SYSTEM (Registration with ANVISA: 10310650029); ADVANTX SFX X-RAY SYSTEM (Registration with ANVISA 10310650031); DIGITAL IMAGE SYSTEM BY X-RAY INNOVA (Model: INNOVA 2000 - Registration at ANVISA 80071260060)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

CRT monitors, CRT monitor feet and CRT suspension systems have exceeded their rated life and are obsolete. Follow the precautions below until the monitor feet on your unit are replaced. • CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are properly secured in the tray before each use. Immediately stop using the system if there is any play on the monitor and contact your GE service representative. • The monitor should not be positioned directly above the patient. • Position the monitor by holding the handle on the side or the front of the tray and gently move it to the desired position, as recommended in the 45-296411 User's Guide. • Before technical assistance or preventative maintenance of the monitor is performed on a GE system by non-GE maintenance personnel, GE strongly recommends that you obtain an updated copy of the preventive maintenance procedures and services from your GE Healthcare representative or download them from the GE Online documentation site. This can be found under the product name. See the current manuals that will be available on the link. The URL of this site is: http://www3.gehealthcare.com/en/Support/Support_Documentation_Library. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.