Events

Safety Alert for Equipment for angiography ALLURA XPER FD10 (floor), FD10 (ceiling), FD20 (floor), FD20 (ceiling), FD10 OR Table; FD20 OR Table; FD10 / 10; FD20 / 20. Risk class: III, Record: 10216710153 and 10216710206.

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 Nederland B.V..

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
    1623
  • Date
    2015-07-02
  • 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
    According to the record holder's information, there is a possibility of collision of the equipment with the patient or with the staff present in the room when the ceiling suspension of the monitors falls to their lowest position. There is also the possibility that the ceiling suspension of the monitors will collide with other equipment that is close to it. #### UPDATED ON 7/18/2017, the company sent a field action completion report confirming the replacement of the part , as provided.
  • Reason
    According to the record holder, a fault in the allura xper system monitor ceiling suspension (mcs) was found.
  • Action
    The company that owns the registry will make a correction in the equipment field. A containment action will be taken in which loops will be attached to the MCS to prevent them from falling. It is recommended that the user does not position or move the monitor ceiling suspension above the patient and do not allow the staff to be below or near the ceiling suspension of the monitor.

Device

Equipment for angiography ALLURA XPER FD10 (floor), FD10 (ceiling), FD20 (floor), FD20 (ceiling),...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA