Alerte De Sécurité sur Commercial name: cobas c 501 module and cobas c 502 module. Technical name: Physiological Fluid Analyzer. ANVISA registration number: 10287410597 and 10287410878. Risk class: I and II. Affected Model:. Serial numbers affected: 4745914001, 5964067001

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.

Customers and users are advised not to over-tighten the bolts when reinstalling the cover after maintenance. When removing screws for maintenance, avoid touching the edge of the USM Cover. If you want to notify technical complaints and adverse events use the following channels: Notivisa: Adverse Event (AE) and Technical Complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link