Events

Safety Alert for Angiography Equipment Allura Xper Brand Philips. Models: Allura Xper FD10 Ceiling / Allura Xper FD10 Floor. 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
    1699
  • Date
    2015-11-06
  • 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
    The severity was classified by Philips as "results in less than moderate damage or does not result in damage" and the probability of occurrence was classified as a "good chance of occurrence". The conclusion of the risk analysis performed by the company was acceptable. No injury was reported attributed to the problem so far according to the company. #### UPDATED ON 7/18/2017, the company sent a completion report of the field action proving the accomplishment of correction, as planned.
  • Reason
    Intermittent electronic defect in the product. under certain circumstances, a software error may lead to a situation where the five-minute fluoroscopy beep is not emitted as required in 21cfr1020.32 (h) (2) (ii) and iec 60601-2-54 , clause 203.6.2.1.C.
  • Action
    Field correction (software update). Failure to emit the audible alarm occurs very intermittently. The user should always observe the real-time dose information and cumulative fluoroscopy time provided by the system. The fault condition is reset when the case of a new patient is started or when the system is reset.

Device

Angiography Equipment Allura Xper Brand Philips. Models: Allura Xper FD10 Ceiling / Allura Xper F...

Manufacturer

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