Commercial name: MAGNETIC RESONANCE IMAGE SYSTEM (Model: DISCOVERY MR750W 3.0T). ANVISA registration number: 80071260134. Hazard class: II. Serial Number (s) Affected: 00000309092MR5, 00000310904MR8, 00001301FMM03E, 00001309FMM072 and 00000000UA0467. 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.

Recommendations to users and patients: Users may continue to use the system following the Safety Information contained in the Operator's Manual on the use of patient pads and observation during the examination. This safety information includes: • WARNING: Place a suitable non-conductive cushion between the patient and the gantry ring whenever a part of the body can come into contact with the magneto opening. • CAUTION: Continuous patient observation and contact are required in all modes of operation. • CAUTION: Extra care should be taken when performing tests on patients who are unconscious, sedated, or who may experience loss of sensation on any part of the body, or who are physically or mentally incapacitated, and unable to alert the staff. If brown discoloration is seen on the inner surface of the gantry, or if a burnt smell is noticed, discontinue the examination. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.