Events

Safety Alert for Angiography equipment, Risk class: III, models described below. Model: ALLURA XPER FD10 (floor), ALLURA XPER FD10 (ceiling), ALLURA XPER FD20 (floor), ALLURA XPER FD20 (ceiling), Registration: 10216710153 ////. Model: INTEGRISH5000 F, Record: 10216710034 ////. Model: Integris Allura 12/15, Integris Allura 12 / 15F, Integris Allura 9C, Integris Allura 9F; Record: 10216710155 ////. Model: ALLURA XPER FD10 / 10; ALLURA XPER FD20 / 10; ALLURA XPER FD20 / 20; ALLURA XPER FD10 / 10 OR Table; ALLURA XPER FD20 / 10 OR Table; ALLURA XPER FD20 / 20 OR Table; Record: 10216710206 .. Serial number: 176; 553; 759; 1751; 001H021796; 001H021878; S4F010159A; S4F200174A; S4F200270A

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
    1514
  • Date
    2015-02-05
  • 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 record holder's information, the risk is linked there is a possibility of collision of the equipment with the patient or with the staff present in the room. When suspended from the ceiling of the monitors, it may fall to its lowest position. There is also the possibility that the ceiling suspension of the monitors collide with other equipment that is close to it.
  • Reason
    According to the record holder, the ceiling suspending system of the equipment monitors may plummet to its lowest position which, after investigation pointed out that the cause of the failure was a montage suspended ceiling trigger assembly error.
  • Action
    The registrant has established the following guidelines for customers until the containment action is implemented: - Do not position or move the ceiling suspension of the monitors on the patient - Do not allow team members to be under or near the suspension monitors.- Avoid any unnecessary movement of the monitors suspended ceiling. " (SEE ATTACHED)

Device

Angiography equipment, Risk class: III, models described below. Model: ALLURA XPER FD10 (floor), ...

Manufacturer

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