Angiography Equipment ALLURA Philips. ANVISA records n ° 10216710153 and 10216710206. Models under risk: Allura Xper FD10 Ceiling / Allura Xper FD10 Floor / Allura Xper FD10 Ceiling / Allura Xper FD10 Floor / Allura Xper FD10 Allura Xper FD20 / 10; Allura Xper FD20 / 20; Allura Xper FD10 / 10 OR Table; Allura Xper FD20 / 10 OR Table; Allura Xper FD20 / 20 OR Table. 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.

If the Pedal is frequently used on an anti-fatigue mat, on an uneven surface or on the pedestal, your pedals may tilt. This can lead to an intermittent or continuous impossibility of obtaining fluoroscopic images or exposures in real time. Before starting a procedure, the user must check if the foot switch has any inclined pedals. If any inclined pedal is identified, the procedure must be interrupted and local service should be called. The inclined pedal can lead to an intermittent or continuous impossibility of obtaining images or fluoroscopic exposures in real time. If the fluoroscopy pedal is tilted and real-time fluoroscopy is not available, the footswitch display pedal or manual key can be used to generate a real-time image to complete a procedure. This will lead to a larger dose. For additional clarifications, access the Safety Notice issued by the company: http://portal.anvisa.gov.br/wps/wcm/connect/dd65d280479e0478916efbfe096a5d32/Aviso+de+Seguran%C3%A7a_1525.pdf?MOD=AJPERES