Events

Safety Alert for Ceiling Suspensions SA Models Powerled, Hled, Standop Hanaulux Voltage Series 3000. Suspensions of ceiling manufactured between March 2012 and June 2012.

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..

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
    1577
  • Date
    2015-05-12
  • 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
    Check additional information in the Alert Message distributed by the company to its customers, available at http://portal.anvisa.gov.br/wps/wcm/connect/c37faa00485cd4f5af0eaf734e60b39c/Seguran%% (On 07/21/2015): affected products were not marketed in Brazil, according to updated information of the company MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA .
  • Reason
    Friction in the double suspensions of the equipment can lead to the detachment of pieces of paint, which may eventually fall into the surgical field of a patient.
  • Action
    MAQUET will carry out on-the-spot checks on its customers, through its authorized technical specialists, to determine if the suspension arms have friction. If this situation is verified the company will schedule the replacement of the suspensions.

Device

Ceiling Suspensions SA Models Powerled, Hled, Standop Hanaulux Voltage Series 3000. Suspensions o...

Manufacturer

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