Safety Alert for Intracranial Pressure Monitor /// Technical Name: Intracranial Pressure Monitor /// ANVISA Record Number: 10175060014 /// Risk Class: III - High Risk /// Model Affected: 06019411 - Neuro Intracranial Pressure Monitor I Plus /// Affected Lot Numbers: See Distribution Map

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.

For products marketed as of 7/31/2016, their commercialization and use should be suspended. The affected products must be segregated and returned to the manufacturer. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (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. ## UPDATE # Field action closure: 12/2/2016. According to the report sent by the company, the products collected from customers and those that were in the company's stock were decharacterized. UPDATED ON 08/16/2017. The reason for the notification was discontinuation of the manufacture of regularized product. This situation does not constitute a motivation for field action, under the terms of RDC No. 23/2012.