Events

Safety Alert for MEDICAL, CEILING, AC POWER, RHYTHM AND MIDMARK POWER LAMPS: (1) MODEL 354 AND (2) MODEL 355. ALL SERIAL NUMBERS MADE BETWEEN JANUARY 4, 200 AND JUNE 20, 2000.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MIDMARK 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
    49
  • Date
    2001-06-08
  • 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
    Lamp arm can cause ceiling by defect in manufacture. midmark began removal by letter sent january 19, 2001. the signature given no information to ecri.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE MIDMARK REMOVAL LETTER OF JANUARY 19, 2000. IDENTIFY, ISOLE AND DO NOT USE THESE PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR MIDMARK REPRESENTATIVE OR PHONE (0021-1-937-526-3662).

Device

MEDICAL, CEILING, AC POWER, RHYTHM AND MIDMARK POWER LAMPS: (1) MODEL 354 AND (2) MODEL 355. ALL ...

Manufacturer

MIDMARK CORP.
  • Source
    ANVSANVISA