Trade name: Optima MR430S Magnetic Resonance Imaging System (Model: Optima MR430S 1.5T); ANVISA record: 80071260327; risk class II; lots / series (place of distribution): MR04082010 (São Paulo-SP); MR05072010 (Brasília-DF); MR07082010 (Vitória-ES); MR07092010 (Goiânia-GO); MR11242009 and MR12142009 (Curitiba-PR); MR12152009 (Florianópolis-SC) /// Model: DISCOVERY MR450, ANVISA registration: 80071260116. 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.

Users should notify GEHC Maintenance Engineers if the Magnet Monitoring Unit (MMU) detects any abnormal or out-of-spec reading. If the Magneto Monitoring Unit (MMU) detects an error, it will display a pop-up window on the system monitor, which will be seen by the operator. The errors shown by the MMU will be in the format: error CAS7XX (being XX, the specific error) with a brief description. If no error is shown on the Magneto Monitoring Unit, no action is required. Affected products can continue to be used normally. If you have any questions about this security alert please call: Metropolitan Capitals and Regions 3004 2525 and Other regions: 0800 165 799 UPDATE ON JUNE 6, 2016, FOR THE INCLUSION OF THE DISCOVERY MR450 MODEL, ANVISA registry: 80071260116. field action: UPDATED ON 10/23/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.