Alerta De Seguridad para M3 MULTIMEDIA MICRO COLLECTOR. Anvisa Registry n ° 80042070017.

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 Brainlab Ltda, treatment plans for the M3 MICRO MULTILINE COLLECTOR typically contain pairs of closed blades and ideally no dose should be administered through the small space remaining between the tips of the enclosed blades of the equipment. However, according to the company a small leak is technically unavoidable, unless this blade gap is covered by the linear accelerator collimator (primary collimators). Therefore, to avoid administering a dose to the patient with undesired radiation leakage, it is essential that the space between the pairs of closed blades of the M3 is always completely protected by the primary collimators of the linear accelerator. If the leaked dose exceeds the clinically desirable limits for a particular treatment plan, severe injury to the patient may result. According to the company, no adverse events related to the problem in question have been reported so far. Anvisa's Technovigilance Unit is monitoring this case.