Events

Safety Alert for Allura Xper FD10 Allure Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 ; 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 / Integris Allura 12/15 Integris Allura 9 / 15F Integris Allura 9C Integris Allura 9F. Affected records: 10216710034 /// 10216710153 /// 10216710155 /// 10216710206 .. Serial numbers affected: 176/553/759/1751 / 001H021796 / 001H021878 / S4F200104A / 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 (Cleveland), Inc..

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
    1542
  • Date
    2015-03-20
  • 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, there were no reports of injuries due to this failure mode, but when the vertical brake malfunctions, the technician, patient or other users who are near the table may suffer an injury.
  • Reason
    According to the record holder there is a possible fault in the monitor stator actuator assembly. failure to do so may cause the monitor to drop and possible collision with other parts of the equipment, professional or patient.
  • Action
    The record holder's recommendations are to not position or move the monitor ceiling suspension above the patient; do not allow the staff to remain below or near the ceiling suspension of the monitors and to avoid unnecessary ceiling suspension movements.

Device

Allura Xper FD10 Allure Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper ...

Manufacturer

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