Events

Safety Alert for COMPONENTS FOR ANESTHESIA WITH SOFTWARE VERSION C.0, OF THE PHYSIOLOGICAL MONITORING SYSTEMS MODELS NOS. (1) M1165A, (2) M1166A, (3) M1167A, (4) M1175A, (5) M1176A, (6) M1177A, EEPROM NOS .: (1 À6) M1059-81242, M1059-81262

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP.

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
    37
  • Date
    2001-03-14
  • 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
    The monitor may erase and resume if the record button on the remote control is tighten in a sustained way, or if an alarm releases, causing transition failure of the functions.
  • Action
    THE MANUFACTURER STARTED WITHDRAWAL IN NOVEMBER / 2000. IDENTIFY AND INSULATE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. EEPROM NUMBERS CAN BE FOUND IN THE SYSTEM COMPONENT IF YOU DO THE FOLLOWING STEPS: (1) PRESS THE INSTRUMENT SETUP OR MONITOR SETUP BUTTON. (2) PRESS THE MORE CHOICES BUTTON IF AVAILABLE. (3) PRESS THE MONITOR REVIEW BUTTON. THE MONITOR REVIEW CIRCLE APPEARS WITH THE EEPROM NUMBER IN THE CENTER OF CAIXA DE CIMA. TO REQUIRE THE ENGINEER TO VISIT WHICH WILL INSTALL FREE TRANSFER VERSION FREE OF CHARGE, CONTACT AGILENT TECHNOLOGIES RESPONSE CENTER BY PHONE 00XX 1 (877) 811-1710 OR (987) 687-1501.

Device

COMPONENTS FOR ANESTHESIA WITH SOFTWARE VERSION C.0, OF THE PHYSIOLOGICAL MONITORING SYSTEMS MODE...

Manufacturer

AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA