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. 의 안전성 경고

Safety alert

1741

2015-11-09

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

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.

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.