Alerta De Seguridad para CIRRUS HD OCT 4000. Anvisa Registration No. 10332030057.

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 of the product in Brazil, when the operator acquires an image of a first patient and then logs the system without analyzing the image data and then enters the system (' login ') to acquire images of a second patient, the data of the second patient can be saved by the system with the name of the first patient. The new software updates the drives with software version 5.0.0 and 5.1.0 and corrects possible data storage inconsistencies caused by the equipment. The problem was detected in two ophthalmological centers outside Brazil.