Events

Safety Alert for CIRRUS HD OCT 4000. Anvisa Registration No. 10332030057.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Carl Zeiss do Brasil Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1060
  • Date
    2011-06-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Ophthalmic diagnostic equipment can overlay images by storing patient data in your database.
  • Action
    The company started the communication to the users on 06/06/2011 for software update, in order to correct the mentioned problem. If you have the product and you are in doubt whether it is affected by the problem, or if you have not yet received the risk communication from the registration holder, contact the company by calling 0800-7705556 and requesting information.

Device

CIRRUS HD OCT 4000. Anvisa Registration No. 10332030057.

Manufacturer

Carl Zeiss do Brasil Ltda.