Events

Safety Alert for EQUIPMENT FOR ANGIOGRAPHY ALLURA XPER, FD10 (ground); FD10 (ceiling); FD20 (ground); FD20 (ceiling); FD10OR Table; FD20 OTable; FD10 / 10; FD20 / 20 OR Table; FD20 / 10 OR Table; registry 10216710153 and 10216710206, hazard class III, series affected: 405/377.

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
    1715
  • Date
    2015-05-15
  • 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's information, intermittent failure of fluoroscopy may result in a temporary discontinuation of procedures and delay in treatment. #### UPDATED ON 7/18/2017, the company issued a completed field action report confirming the performance of correction, as provided.
  • Reason
    Software failure that can lead to intermittent and short-term unavailability of the fluoroscopy function.
  • Action
    The company will update the software, installation of version R8.2.16.1, to correct the problem. The company clarifies that upon initiating fluoroscopy, the user may receive a "Fluoro failed, please retry" message and Fluoroscopy will be unavailable. Fluoroscopy repeat solves this situation in most cases. The user may need to repeat more than once in approx. 2% of events. The failure mode has no impact on the performance of active fluoroscopy. Once started, performing an active fluoroscopy continues until the pedal is released.

Device

EQUIPMENT FOR ANGIOGRAPHY ALLURA XPER, FD10 (ground); FD10 (ceiling); FD20 (ground); FD20 (ceilin...

Manufacturer

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