Events

Safety Alert for Generators of Radio-Frequency Model 4810. UPN. M00448100

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific/EP Technologies.

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
    552
  • Date
    2000-03-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    An ecri member hospital reported that there was a failure of communication between the micro-electronic program components in the above radio-frequency generators. this communication failure puts the device in fail-safe mode, rendering it inoperative. the manufacturer states that this problem began on january 2, 2002. the manufacturer initiated a correction for a notification during the week of january 7, 2002 by federal express.
  • Action
    Verify that you received the January 2002 Boston Scientific Correction Notice. Identify and isolate any affected product in your inventory. If your unit (s) has not received coverage from this service, please contact your EP Technologies sales representative, who will put you in touch with the appropriate person at Boston Scientific. For more information, contact Boston Scientific / EP Technologies in the USA by phone at (1408) 895-3626, or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Generators of Radio-Frequency Model 4810. UPN. M00448100

Manufacturer

Boston Scientific/EP Technologies
  • Source
    ANVSANVISA