Alerta De Seguridad para Products affected by the Field Action: (i). Cardioversor Life 400 Plus Futura - Registration: 80058130010 - Class III; (ii). Cardioversor Vivo - Registry: 80058130015 - Class III. DISTRIBUTION MAPS (IN BRAZIL AND TO THE EXTERIOR) AND SERIES AFFECTED IN ANNEX.

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.

According to CMOS DRAKE, "The watchdog circuit already existing on the Cardioversor has the sole and exclusive purpose of resetting the equipment in case the equipment is locked for external reasons. It is not mandatory, as it does not influence stability, safety, does not affect performance and does not change the functional characteristics of the equipment. The mentioned technical intervention will allow the Watchdog circuit to work within a range closer to the limits calculated for the reset, guaranteeing better performance of the circuit in question. "##### UPDATE: On 02/22/2016 Certification of Good Manufacturing Practices of CMOS Drake of Nordeste Eireli - CNPJ: 03.620.716 / 0001-80, published by Resolution RE No. 4,482, of 11/14/2014, published in the DOU nº 222, of 11/17/2014 ( Section I, pages 43 and 44, and in Supplement to Section I, page 168), considering the non-compliance with the Good Manufacturing Practices requirements set forth in current legislation for the Health Products area. / 04/2016 was rejected the request Certification of Good Practices of Manufacture of Health Products of the Company DC Heart Defibrillators and Medical Systems Ltda. - CNPJ: 13.676.954 / 0001-60, through RESOLUTION - RE N ° 1,043, OF 20 OF APRIL 2016, published in DOU DE 04/25/201 6 ## UPDATE ON 07/4/2016: CANCELLATION BY THE CERTIFICATION ORGANIZATION OF THE CERTIFICATES FOR THE REFERRED PRODUCTS, AS FOLLOWS "II - Cancellation by other types of non-conformities not related to tests. Evidences of non-conformities and deviations from process encountered in the QMS during the maintenance process. " ## UPDATE: On 08/18/2016 Intertek issued the Certificates Numbers MED 0521 / C 0689.16 and MED 0521 / C 0688.16, for the Vivo Cardioversor products - Registration: 80058130015 and Cardioversor Life 400 Futura - Registration: 80058130008, respectively.