Alerta De Seguridad para SERVO VENTILADOR TAKAOKA - register 10229820070, model MONTEREY

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 art. 7 of Law no. 6,360, of September 23, 1976, combined with art. 8 of Decree No. 79.094, of January 5, 1977, considering items 3, 4, 9.2 and 12.8.1 of the technical regulation of the general requirements of RDC No. 56, of April 6, 2001; considering also the notifications of Technovigilance that report the occurrence of serious adverse events with said product, resolves: Article 1 - To determine, as a precautionary measure, the sanitary interest throughout the national territory, the suspension of commercialization and production of the SERVO product TAKAOKA VENTILATOR - registration 10229820070, model MONTEREY, manufactured by the company K. TAKAOKA INDÚSTRIA E COMÉRCIO LTDA. BRASILIA-DF, 27 DECEMBER 2004 RESOLUTION - RE Nº 1.991 , DECEMBER 15, 2004. Considering the dispatch by the Tecnovigilance Unit in file 362305 / 04-0 regarding the final report of the performance tests, safety and alarms of the Monterey Model TBAoka Ventilator Fan of the PEB-5077-B project of the COPPETEC indicating satisfactory results, resolves: Art. 1º Determine the release for manufacturing and commercialization of the products SERVO FAN MONTEREY COMPRESSOR and SERVO VENTILADOR TAKAOKA , manufactured by K. TAKAOKA INDÚSTRIA E COMÉRCIO LTDA.