Company: Philips Electronics North America Corporation
Date of Enforcement Report 2/10/2016
INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
Recall Number Z-0717-2016
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Philips Electronics North America Corporation, Andover, MA on 11/3/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13297 in total
Nationwide and Internationally