Angiography Equipment ALLURA XPER. Register Anvisa n ° 10216710153. Products under risk in Brazil: models with codes 722003,722005, 722006, 722008, 722014, 722015, 722019, 722020 with software version 7.2.X. 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.

This is an electronic defect in the intermittent alarm of the product, which in certain circumstances may lead to a situation in which the five-minute sound signal from the fluoroscopy does not sound. Through customer complaints and internal testing, Philips Healthcare has discovered an intermittent electronic defect in the product. According to the company, the problem does not create a dangerous situation, however the beep is an available tool to help avoid the excessive incidence of radiation in the patient. See Security Notice published by the company, available at: http://portal.anvisa.gov.br/wps/wcm/connect/f4260380478c61258259ebfe096a5d32/Aviso+de+Seguran%C3%A7a+-+FCO72200270.pdf?MOD=AJPERES