Events

Safety Alert for Trade Name: SURGICAL TABLE; Model MAGNUS 1180; registration: 80259110066; risk class I; Series numbers affected in Brazil-distributed in the Municipality of São Paulo-SP: 99; 142; 144; 145 distributed in the Municipality of Rio de Janeiro-RJ: 239; 241; 243.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET GMBH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1856
  • Date
    2016-04-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recommendations to users and patients: Check at the time of use of the equipment whether the basic table top is locked on the conveyor or if it needs to be transferred to the conveyor, make sure that the extension device is attached to the side opposite the battery holder and conveyor belt bar. ### UPDATED ON 04/09/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Reason
    Maquet within the scope of market surveillance has learned that, due to improper handling under unfavorable circumstances, the magnus 1180 table extension device can be unlocked from the tabletop and fall. this problem may occur when the device is not used according to the description in the instructions for use and the operator does not pay attention to possible collisions. in extreme cases, collisions with an obstacle under the tabletop can lead to the problem described above. the extension device may from the operating table mounting point if: • the table top with mounted accessories is moved against obstacles; • the assembled table top with accessories is transferred to the conveyor incorrectly with the foot and head ends inverted.
  • Action
    Code of the action CAPA 2016-002. Send of letter of report for the customers that have equipment affected ////// Sending of technicians to the place of equipment affected for installation of new accessory.

Device

Trade Name: SURGICAL TABLE; Model MAGNUS 1180; registration: 80259110066; risk class I; Series nu...

Manufacturer

MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET GMBH
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    ANVSANVISA