EQUIPMENT FOR ALLURA XPER ANGIOGRAPHY. Anvisa Registry No. 10216710153 and 10216710206. Affected series: 575, 302, 405, 914, 596, 1193, 602, 576, 619, 1687 and 407. 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.

When the ceiling monitor suspension falls to its lowest position, there is a possibility of a serious adverse event occurring with the patient or users. The company informed that it will carry out corrective field actions with the affected products in Brazil (FCO72200211). For further information, check http://portal.anvisa.gov.br/wps/wcm/connect/77402d004ba13af7bd1cbfaf8fded4db/Messagem+de+Alerta.pdf?MOD=AJPERES.