Events

Safety Alert for Commercial Name: Brightview XCT Image System Technical Name: Equipment Positron Emission Tomography ANVISA Registration Number: 10216710189 Hazard Class: III Model Affected: Serial Numbers Affected: 6000276

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. / 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
    2215
  • Date
    2017-03-02
  • 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
    Discontinue use of the system immediately, until the Philips service implements the inspection, and if necessary, the correction. #### UPDATED ON 7/18/2017, the company submitted a completion report of the field action informing the proof of compliance of product.
  • Reason
    The detector locking systems may become inoperative, resulting in movement to the mechanical limit of one or both of the detectors. in the case of this type of fault, the movement of the detector can not be suspended using normal operator intervention (e-stop, activation of the collimator contact sensor).
  • Action
    Field Action Code FCO88200502 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will make correction in the field.

Device

Commercial Name: Brightview XCT Image System Technical Name: Equipment Positron Emission Tomograp...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. / Philips Medical System...
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA