Trade name: Flow-i Anesthesia System; Technical Name: anesthesia machine. ANVISA registration number: 80259110091; Risk class: III; Affected model (s): C20, C30 and C40; and Batch (s) / Serial number (s) affected: Attached document 의 안전성 경고

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.

The technical alarm generated is a warning device that prompts the user to take measures such as reducing the flow of fresh gas (to keep the anesthetic in the breathing circuit) and / or injecting intravenous medications necessary to ensure sufficient depth of anesthesia. ## UPDATED ON 04/09/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.