Events

Safety Alert for CAMERA GAMMA VERTEX TM V60; Brand Philips; Risk class III; serial numbers: 01894VM; Z01798VM; 00970VA; 40050223.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; ADAC Laboratories (A Philips Medical Systems Company).

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
    1547
  • Date
    2015-03-27
  • 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
    According to the registry holder, there was an accident report of the equipment with an operator. The accident resulted in an injury to the operator.
  • Reason
    Collimation cassette misalignment on upper guide bearings when manual override causes collimator to drop and cassette.
  • Action
    According to record holder guidelines, if the customer visually identifies a misalignment at the top and / or bottom of the guide rail between the cabinet and the car, the collimator replacement procedure should not be continued. The misalignment problem can only be solved during a maintenance operation.

Device

CAMERA GAMMA VERTEX TM V60; Brand Philips; Risk class III; serial numbers: 01894VM; Z01798VM; 009...

Manufacturer

Philips Medical Systems Ltda.; ADAC Laboratories (A Philips Medical Systems Company)
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA