Company: Philips Electronics North America Corporation
Date of Enforcement Report 2/10/2016
Class lI:
PRODUCT
UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: ” Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). ” Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures
Recall Number Z-0709-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
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
DISTRIBUTION
Nationwide and Internationally
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