Safety Alert for X-ray Equipment (Miscellaneous)

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.

The installation of this type of equipment in clandestine workshops or in the health service itself can pose a great risk to the health of the patient, the operator of the machine and other people who transit in the vicinity of where the equipment operates. The granting of registration of the X-ray Equipment in Anvisa is conditional, among other requirements, the presentation of the INMETRO Certification of Conformity of the equipment. In the certification are evaluated, through laboratory tests, electrical safety, mechanical and radiation emission requirements of the equipment, based on specifications established in technical standards of the Brazilian Association of Technical Standards - ABNT; are still evaluated, through factory inspection, requirements of the Quality System of the company with respect to the production process of the equipment. Therefore, considering the nature of the radiation emitted by the equipment, the use of products that have not been evaluated by Anvisa in relation to the compliance with the necessary safety criteria, can pose a great risk to the health of the population, besides characterizing sanitary infraction under the Law 6437/1976. It is still framed in Crimes Against Public Health, in which the offenders are subject to the penalties set forth in art. 273 of the Brazilian Penal Code (Decree Law No. 2848/1940), incurring in the same penalty who imports, sells, exhibits for sale, holds on deposit to sell or, in any case, distributes or delivers the product without registration, when required , in the competent sanitary surveillance body. We inform you that according to RDC Anvisa no. 185/2001 (article 4) medical equipment must have affixed to your body an indelible label that includes: the name and commercial model of the product, your registration number with Anvisa, the name of the its manufacturer and its serial number. To verify the regularization in the Anvisa of the X-ray Equipment and of other medical products, access: http://www.anvisa.gov.br/scriptsweb/correlato/correlato.htm