Events

Safety Alert for RX PCR Scanner ELEVA. Anvisa Registry: 10216719006.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems 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
    957
  • Date
    2009-03-11
  • 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
    The cited problem can occur every time the following events occur simultaneously: a patient is selected in the patient list, the examination tab is pressed and a query to the database is running at the same time in the background. According to Philips Medical System Ltda (holder of product registration in Brazil), the equipment will be updated with a software version that will correct this error. The company has not yet released the timeline for correcting the error. The ANVISA Technovigilance Unit is monitoring this case.
  • Reason
    The equipment may perform an incorrect selection of patients, which may cause confusion of data belonging to different patients.
  • Action
    The recommended action for product users is that, before saving the images, check the patient selection list if the correct patient is selected.

Device

RX PCR Scanner ELEVA. Anvisa Registry: 10216719006.

Manufacturer

Philips Medical Systems Ltda.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA