Events

Safety Alert for OXIMETER, PULSE OXYGEN SATURATION MODULES COMPATIBLE WITH M-NSAT DATEX-OHMEDA NELLCOR

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DATEX-OHMEDA AN INSTRUMENTARIUM CO; DATEX-OHMEDA.

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
    59
  • Date
    2000-12-25
  • 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 spo2 value may freeze on the monitor of the above systems when used in combination with an interface plate (b-int) or interface module (m-int).
  • Action
    MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT AS OF 26 DECEMBER 2000 BY DATEX-OHMEDA. IDENTIFY AND ISOLATE ANY AFFECTED PRODUCT IN YOUR STOCK. FOR FURTHER INFORMATION, PLEASE CONTACT DATEX-OHMEDA BY PHONE (800) 345-2700

Device

OXIMETER, PULSE OXYGEN SATURATION MODULES COMPATIBLE WITH M-NSAT DATEX-OHMEDA NELLCOR

Manufacturer

DATEX-OHMEDA AN INSTRUMENTARIUM CO; DATEX-OHMEDA
  • Source
    ANVSANVISA