Alerte De Sécurité sur Product: INFINIA - Registration: 80071260049 - Risk Class III - High Risk - Technical Name: Nuclear Imaging System - Model: GE Healthcare Systems Infinia and Infinia Hawkeye Nuclear Medicine, Millennium VG, VG Hawkeye and VariCam Nuclear Medicine, all the settings (SEE APPENDIX)

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.

GE Healthcare "recommends that users monitor patients and systems throughout the scanning procedure to ensure there is sufficient space between the patient and the detectors. If the detector comes into contact with the patient, the user must press the Detector Out button on the Remote Control Unit to reverse the movement of the detector. If any unintended movement of the detector is identified, the user must press the Emergency Off button on the console or gantry to stop this movement and pull the patient release handle to remove it as indicated in the manual of user. When using Pressure Sensitive Devices in the gantry, this may not stop unintended movement of the detector. If you see error # 147 on axis 1, it will need to follow the instructions in the user manual and contact GE Services. "(LETTER TO CUSTOMERS IN ANNEX)