Events

Safety Alert for Angiography Equipment Allura Xper. Model (s): FD10 (floor); FD10 (ceiling); FD20 (ground); FD20 (ceiling); FD10 OR Table; FD20 OR Table; FD10 / 10; FD20 / 20; FD20 / 10; FD10 / 10 OR Table; FD20 / 20 OR Table; FD20 / 10 OR Table. Anvisa Registry n ° 10216710153.

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
    1744
  • Date
    2015-11-18
  • 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 company, the severity was classified as "results in less than moderate damage or does not result in damage" and the probability of occurrence was classified as a "considerable chance of occurrence". The audible signal is one of the tools available to help prevent unnecessary radiation to the patient. No injury attributed to the problem was reported. #### UPDATED ON 7/18/2017, the company submitted completion report of the field action verifying the accomplishment of correction, as expected.
  • Reason
    Philips healthcare has discovered, through customer complaints and internal testing, an intermittent electronic defect of the product. in certain circumstances, a software error may result in a situation where the five-minute audible audible signal does not sound, as required by standards 203c (10cfr1020.32 (h) (2) (ii) and iec 60601-2054, clause 203.6 .2.1.C.
  • Action
    The not ringing of the bell occurs quite frequently. The user must always observe the real-time dose information and the cumulative fluoroscopy time provided by the system. The fault condition is reset when a new patient is entered or when the system is restarted. Company code for field action: FCO72200285

Device

Angiography Equipment Allura Xper. Model (s): FD10 (floor); FD10 (ceiling); FD20 (ground); FD20 (...

Manufacturer

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