Alerte De Sécurité sur Holter Central, Computerized Arrhythmia Analysis System, Arterial Pressure Holter, Analog and Digital Holter Recorder, Event Recorder Loop, Central Cardiac ICU, CardioScan

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.

considering paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the provisions of Article 12 of Law 6360 of September 23, 1976; considering items IV, V and XXIX of Article 10 of Law 6,437 of August 20, 1977; considering items IX, XV, XXIV, XXVI, of Article 7 of Law 9782, of January 26, 1999; considering the Inspection Report held in the company on 08/28/03; considering the AIF Infringement Notice 101, No. 09884, dated September 2, 2003, drawn up by VISA-DIR-I / SES-SP, resolves: Art. 1 To determine, as a precautionary measure, as a measure of health interest, in all national territory, suspension of the sale and manufacture of Central Holter products, Computerized Arrhythmia Analysis System, Arterial Pressure Holter, Analog and Digital Holter Recorder, Event Recorder Loop, Central Cardiac ICU, CardioScan