Alerta De Seguridad para HEATED UMIDIFIER SERIES M - Models 1051158, 1051157, 1049124, 1049110, 1049109, U1049110, U1049109, R1049110, R1049109 - Registered at Anvisa under number 80102510248 - LOTS / SERIAL NUMBERS - See attached list.

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.

This action does not require changing the humidifiers that are operating normally. In addition, CPAP devices used with the humidifier are not affected by this action and end users with affected humidifiers can continue to operate their CPAP therapy devices without the humidifier. Note that only humidifiers with DC power are affected by this action. Humidifiers with AC food are not affected. We have included a figure in the Letter to Users to assist end users / patients in identifying DC powered humidifiers. (Source: VR Medical) Anvisa is following this action.