Alerta De Seguridad para Product name: EV1000A - INTENSIVE CARE MONITOR (Vital Signs Monitor) / model EV1000A / registration 80219050127 / risk class III - High Risk // Series affected: document attached.

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.

Action Recommendation to be Taken by the User: All EV1000A systems installed are within the scope of this action. This is a way to remind you that the EV1000A Manual alerts you to immersion of the device or its components into fluids and warns you to prevent fluids from entering the devices (the reference is included in the "Safety and Precautions" section of the Operator), and that the external power cable for the EV1000A must be installed as shown in the manual (Figures 15-8 of the EV1000 Power Adapter Mounting Bracket section and Figures 15-9 of Power Cable Bracket Adapter, included in the Manual), where the AC cable connects to the source, as suggested in the illustrations. Please take this opportunity to review how your EV1000A is installed and the system settings at the installation site to make sure it is configured and installed as per the operator's manual specifications in order to minimize any possible risk of fluid in the source or cables.