IMRI Registration Matrix for GE Head Support. Anvisa Registry n ° 80042070034. 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.

As a result, movement of the Registration Matrix (which contains the RM and infrared markers required for navigation) may occur relative to the GE Head Holder and, as a consequence, to the patient's head. In the event of a very large movement, especially a significant rotational movement, the upper part of the recording matrix (weighing approximately 1.3 kg) may reach the patient's face, resulting in physical trauma and, in a worst case, in severe injury to the patient. In the case of minor movements, especially those related to performing an MRI acquisition and to the automatic recording performed by navigation, there is the potential for failure to correspond between the MRI data sequence and the patient's actual anatomy. The result of automatic registration must always be verified by the user to ensure that accuracy is adequate for the planned procedure. It is likely that, in most cases, any offset from the top of the iMRI Registry Matrix is ​​significant enough to be easily recognized during the verification. However, if an inaccurate record is not detected during user verification, a significant deviation can be added to the positions of the instruments virtually displayed by Brainlab navigation in the region of interest and this may mislead the user in making clinical decisions.