Safety Alert for lung ventilators

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VENT-LOGOS Sistema Logístico S/A.

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
    759
  • Date
    2003-12-23
  • 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
    considering the provisions of paragraph 3 of Article 111 of the Internal Regulation approved by Administrative Rule no. 593, dated August 25, 2000, republished on December 22, 2000; considering items IV, XXIX, and XXXV of Art.10, of Law no. 6.437, of August 20, 1977; considering Arts. 1, 12, 17 item X and 25, of Law no. 6.360 / 76, of September 23, 1976; considering art. 1 of DRC-59, of 27 June 2000; considering a report of the joint inspection with the Technical Team of the Sanitary Surveillance of the Secretary of State of Health of Espírito Santo on December 5, 2003, reporting the nonconformities recorded in the Company's Quality System VENT-LOGOS SISTEMAS LOGISTICOS S / A, ; considering the Notice of Infringement No. 307935 and the Term of Interdiction No. 307935 issued by the State Department of Health of the State of Espírito Santo, resolves: Article 1 - To determine, as a precautionary measure, throughout the national territory, suspension of sale and banning of all products (pulmonary ventilators)
  • Reason
    Failure to comply with the requirements of good manufacturing practices established in drc 59/00;.
  • Action
    Suspension of sale and banning of all products

Device

Manufacturer