Alerta De Seguridad para Trade name: SURGICAL TABLES. Technical name: SURGICAL TABLES. ANVISA registration number: 80259110065. Risk class: - Low Risk. Model affected: MOBILE SURGICAL TABLES. Serial numbers affected: All units manufactured in the period between 2009 and 2013.

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, since they can not ensure that other Devices affected by improperly welding have been placed on the market, the component of all possibly affected Devices (1002.65A0) manufactured within the period between 2009 and 2013 will be replaced . In this way, MAQUET's service department or a service technician authorized by MAQUET will contact the customer to arrange a replacement date without charge. The device must be inspected before any use until replacement is performed. In this particular context, special attention should be paid to possible cracks in the weld. According to the company, so far, no incident has been reported in which someone has been injured. It is likely that the break was caused due to improperly welded together with rough handling and multiple application of overload by the user, respectively. ATTENTION: If in doubt, it is advisable that the Device is not used. ### UPDATED ON 10/16/2017, company forwarded evidence and documents proving the correction of the parts and closing the field action. 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