Alerta De Seguridad para CENTRIFUGAL COMBAT (ANVISA Registry No. 80197039011), affected batches: 100804 and 110115 (series: from 6334 to 6391), affected batches: 100804 and 110115 (series: from 6334 to 6391) .

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 the company, the field action was initiated in view of a complaint from a customer, who noticed that the engine of the equipment was slack, produced unusual noise and stopped suddenly during use. After a root-cause analysis, it was detected that the motor support was broken and that it had small cracks, possibly due to inadequate design of the motor base. The company made improvements in the part and validated the new project, through tests of operation under extreme conditions of use. #### Update (10/26/2012): The company reported having terminated the corrective action on August 23, 2012, correcting 96 equipment (out of a total of 108 units).