Commercial name: Flourospeed 120 X-ray table. Technical name: X-ray tables. ANVISA registration number: 10369010035. Risk class: III. Affected Model: Flourospeed 120. Serial Numbers Affected: 0462M41705; 0262M43703; 0262M44405; 0262M43704; 0262M43902. 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.

After the action, the product can be operated normally without recommendation. Prior to the Field Action, a letter will be sent alerting customers of this possibility and requesting that they be aware of any abnormality in the movement of the rooftop until the field action is completed. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 05/15/2017 - Date of notification notice to Anvisa: 05/07/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa.