Events

Safety Alert for X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY. Anvisa Registry No. 10216710193. Affected units: EP16E100069, EP16E110084, EP16E110014, EP16E110044, EP16E110083, EP16E110012, EP16E110021, EP16E110008, EP16E110070, EP16EB110003, EP16EB110004, EP16EB110005 and EP16EB110006.

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
    1190
  • Date
    2012-10-05
  • 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 company, if the oil accumulator or other parts are released and the Gantry covers are open while the appliance is in maintenance mode, the maintenance engineer may be struck by the accumulator of ejected oil or other parts. The company's forecast is to terminate the action on 03/22/2012.
  • Reason
    A bolt that secures the oil accumulator inside the gantry may fail, resulting in the separation of the oil accumulator from the tube mounting inside the gantry.
  • Action
    Check your inventory if you have the affected products, if so, carefully read the instructions in the Alert of the product registration holder (Philips Medical Systems Ltda) and, if necessary, contact the company. The equipment serial number is located on the back of the Gantry. Detailed information to identify your system is available in Appendix B of the Alert Message posted by the company - www.xxxxx.

Device

X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY. Anvisa Registry No. 10216710193. Affected units: EP16E1...

Manufacturer

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