Safety Alert for Equipment for angiography ALLURA XPER, brand PHILIPS, Risk class: III, model: ALLURA XPER FD10 (floor), ALLURA XPER FD10 (ceiling), ALLURA XPER FD20 (floor), ALLURA XPER FD20 (ceiling), Registry: 10216710153; ///// ALLURA XPER ANGIOGRAPHY EQUIPMENT, model: ALLURA XPER FD10 / 10; ALLURA XPER FD20 / 10; ALLURA XPER FD20 / 20; ALLURA XPER FD 20/15; ALLURA XPER FD10 / 10 OR Table; ALLURA XPER FD20 / 10 OR Table; ALLURA XPER FD20 / 20 OR Table; ALLURA XPER FD 20/15 OR Table .. risk class III, registration 10216710206.

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
    1741
  • Date
    2015-11-09
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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 manufacturer makes it clear that real-time images and still images can lead to misinterpretation of still images as real-time images. The system is working according to the specification and purpose of the use.
  • Reason
    According to the record holder, the use of the allura xper, allura clarity, allura cv, allura centron and uniq systems in real time and still images can lead to misinterpretation of still images as real-time images. this can happen when: /// 1. when performing fluoroscopy, the user presses the single-shot exposure pedal, resulting in the display of a single-shot static image on the screen. the user does not realize that the single-shot exposure pedal is still active, and that exposure is therefore still active. conceptually, exposure image acquisition has priority over fluoroscopy imaging, so fluoroscopy is not started until the exposure pedal is released. at the same time, the user does not realize that real-time x-ray image acquisition is not active, although the static image icon is displayed and all legally required real-time x-ray indicators (such as dose, active x-ray icon, fluoro timer, and audible signal-x-ray company) are inactive. 2. while a fluoroscopy pedal is pressed and the fluoroscopy is active, the user (accidentally) presses a second fluoroscopy pedal and then releases the first fluoroscopy pedal. by releasing the first fluoroscopy pedal, the system terminates image acquisition in real time. the user does not realize that the first pedal was still pressed by pressing the second fluoroscopy pedal. at the same time, the user does not realize that real-time x-ray image acquisition is not active, although the static image icon is displayed and all legally required real-time x-ray indicators (such as dose, active x-ray icon, fluoro timer, and audible signal-x-ray company) are inactive.
  • Action
    The field action deals with the sending of Safety Notice for customer orientation. The warning gives the following recommendations to the customer / user: • The user must ensure that the audible signal (X-ray company) is activated. • The user must be aware of the indicators related to the X-ray, ) as described in the instructions for use (IFU). // • The user must activate only ONE fluoroscopy pedal at a time. // • To avoid the simultaneous use of two fluoroscopy pedals, the predicted measurements are working for all pedal models and available for use with the system. // • Users are strongly advised to set the foot switch to the default setting of Philips. // • The user must be aware that pressing a single-shot exposure pedal results in the display of the static exposure image while the single-shot exposure pedal is pressed as described in the instructions for use (IFU) .//// Philips reminds customers to only use one fluoroscopy pedal at a time. Action code: FCO 72200276.

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    ANVSANVISA