Alerta De Seguridad para VISION STRYKER SURGICAL REFLECTOR. Registro Anvisa n ° 80005439007 .. Products affected: all serial numbers belonging to the codes (product codes) described in the annex http://portal.anvisa.gov.br/wps/wcm/connect/f933b60048c63f1dae8eafa3f2835ae8/Alerta_1097_Carta_aos_clientes.pdf? MOD = AJPERES.

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 information received by the UTVIG, there are 25 units potentially affected by the problem in Brazil. In its risk assessment for the case, the company has presented some potential hazards and damages that may result from nonconforming installations: loss of video signal, non-operation of the failure latches and overheating of light cranks (which may system components, such as flexible arms, surgical lights, flat panels, etc.). According to the company, the probability of occurrence of such events is remote and no related adverse events have been reported to the company so far. #### UPDATE - 10/01/2012 - The company forwarded file 0037019 / 12-3 , where he reports the completion of the field action, and all clients were informed. ####