Safety Alert for ADULT / PEDIATRIC RESPIRATORS MODELOO 1000 BEAR; WE. CATALOG 50-08550, 50-08555, 50-08560, 50-08570; WE. OF SERIES 11008756 to 11008959; AND PLATES EPI: CICUIT BOARDS REPLACED BETWEEN 17 JANUARY 200 AND 28 APRIL 2000.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BEAR MEDICAL SYSTEMS INC SUB THERMO ELECTRON CORP.

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
    173
  • Date
    2000-06-02
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    There is the possibility of corrosion of the mechanical relay that activates the energy fall alarm in the respirators mentioned. the manufacturer began a correction by correspondence sent on june 2, 2000.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT ON JUNE 2, 2000, BY BEAR MEDICAL SYSTEMS. IDENTIFY ANY AFFECTED PRODUCT IN YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE BEAR MEDICAL SYSTEMS DEPARTMENT OF TECHNICAL SERVICES BY PHONE 1 (760) 778-7300 IN THE UNITED STATES.

Manufacturer