Events

Safety Alert for X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Registry: 10216710191; ///. . Ingenuity CT, Record: 10216710209; ///. Serial numbers: 58524531; 5,877,142; 61676906; 61701347; 61877637; 61965826; 6,213,815; 62218321; 62829796; 6,308,7087; 63090577; 6,374,4537; 63820666; 63842205; 63912144; 63929459; 64046882; 64075140; 62506739.

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
    1508
  • Date
    2015-02-11
  • 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 registry holder there is a possible vertical brake failure, which may lead to uncontrolled movement of the patient's bed. there are no reports of users being injured.
  • Action
    The record holder's recommendations, in the event of an uncontrolled vertical movement of the patient's bed, the use of the equipment should be discontinued and the user should contact the local care provider. The company does not guide stopping in the use of the bed. Users who prepare and operate the system with the patient should be aware while the patient is on or near the Patient Bed, especially in the case of intubated patients or in similar situations. These guidelines must be followed until the equipment is corrected.

Device

X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Reg...

Manufacturer

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