Safety Alert for Operating Name: Operating Table Mindray. Technical name: Surgery table. ANVISA Registration Number: 80102510865. Hazard Class: I. Model Affected: HYBASE 6. Serial Numbers Affected: G9-73005586; G9-73005587; G9-73005588.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR Medical Importadora e Distribuidora e Produtos Médicos Ltda; Nanjing Mindray Bio-Medical Eletronics LTDA.

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
    2362
  • Date
    2017-08-15
  • 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
    Since there were no sales of the tables still in Brazil, as they are still in stock in our distributor there is no need to indicate recommendations to users and patients. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    During the quality inspection routine carried out by the manufacturer, some screws on the surgical table did not have the desired fixation, which can affect the stability of the table and in extreme conditions causing critical failures.
  • Action
    Field Action Code AC 008-17 triggered under the responsibility of the company VR Medical Importadora e Distribuidora e Produtos Médicos Ltda. Adjustment for tightening screws.