Equipment for angiography ALLURA XPER FD10 (floor), FD10 (ceiling), FD20 (floor), FD20 (ceiling), FD10 OR Table; FD20 OR Table; FD10 / 10; FD20 / 20. Risk class: III, Record: 10216710153 and 10216710206. 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.

According to the record holder's information, there is a possibility of collision of the equipment with the patient or with the staff present in the room when the ceiling suspension of the monitors falls to their lowest position. There is also the possibility that the ceiling suspension of the monitors will collide with other equipment that is close to it. #### UPDATED ON 7/18/2017, the company sent a field action completion report confirming the replacement of the part , as provided.