Events

Safety Alert for Allura CV20 X-ray system, risk class III, registry: 10216710186, batches affected: 87/154.

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
    1621
  • Date
    2015-07-02
  • 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 audible fluoroscopy signal is a tool available to avoid unnecessary radiation to the patient. The non-ringing of the bell occurs very often. #### UPDATED ON 7/18/2017, the company submitted completion report of the field action proving the accomplishment of correction, as planned.
  • Reason
    The record holder has an intermittent electronic defect in the product. a software error may lead to non-activation of the fluoroscopy five-minute bell as required in 21cfr1020.32 (h) (2) (ii) and iec 60601-2-54, clause 203.6.2.1.C.
  • Action
    The record holder's recommendations are that the user should always observe the real-time dose information and the cumulative fluoro time provided by the system. The company will update the software to correct the problem.

Device

Allura CV20 X-ray system, risk class III, registry: 10216710186, batches affected: 87/154.

Manufacturer

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