Company: Philips Electronics North America Corporation
Date of Enforcement Report 5/9/2018
Class II:

PRODUCT
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Recall Number Z-15894-2018

REASON
After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.

RECALLING FIRM/MANUFACTURER
Philips Electronics North America Corporation, Andover, MA on 3/14/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2

DISTRIBUTION
Nationwide and Internationally