Commercial Name: Brightview XCT Image System Technical Name: Equipment Positron Emission Tomography ANVISA Registration Number: 10216710189 Hazard Class: III Model Affected: Serial Numbers Affected: 6000276 의 안전성 경고

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.

Discontinue use of the system immediately, until the Philips service implements the inspection, and if necessary, the correction. #### UPDATED ON 7/18/2017, the company submitted a completion report of the field action informing the proof of compliance of product.