Events

Safety Alert for GO BED HOSPITAL BED - Model FL28EX - Record 80005430271 - Lots Affected - see attachment. http://en.wikipedia.org/w/eng/index.php/

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Stryker do Brasil Ltda..

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
    1210
  • Date
    2012-12-06
  • 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
    Stryker has received complaints regarding scales and / or bedding systems for the Go Bed Bed - mod. FL28EX, with scale or bed output (Chaperone). This unit was manufactured between March 1, 2002 and June 30, 2008. Their investigation identified that the reported problems could be attributed to the malfunctioning of charge cells. See more information in the attached Letter of Attachment. #### Update (02/01/2013): field action closed on 12/27/2012 by the record holder.
  • Reason
    Malfunction of load cells.
  • Action
    See attached letter. http://en.wikipedia.org/w/eng/index.php

Device

GO BED HOSPITAL BED - Model FL28EX - Record 80005430271 - Lots Affected - see attachment. http://...

Manufacturer

Stryker do Brasil Ltda.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ANVSANVISA