Alerte De Sécurité sur Product name: Vital Signs Monitor ANVISA Registration Number: 80145901192 Hazard Class: III Affected Model: CARTO 3 System Affected Series Numbers: SKU: FG540000 | SNs: 13173; 13213; 11567; 14218; 13208; 50203; 50531; 14718; 14528; 50573

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.

1. Carefully read the Medical Device Correction notice. 2. If there is a CARTO® 3 System currently in the hospital, the system has already been corrected and you should check if you received a Field Service Report, stating that the "system is in order". 3. Analyze, complete, sign and return the Confirmation Form, according to the instructions on the form. 4. In the future, if a CARTO® 3 System is installed in your hospital, you should perform a clinical procedure only after you have received a Field Service Report with a date after the device is installed, indicating that the "system is in order". 5. Stay aware of this notification and pass it on to everyone at your facility who needs to be informed.