The Allura Xper series is intended for use on human patients to perform: ...



The Allura Xper series 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 implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures."
Components:
Recall Date:    Aug 13, 2021
Mfg:
Philips North America Llc
Mfg Country:
United States
Recall ID:    88546
Product ID:    188964
Enforcement Date:    Sep 22, 2021
Last Published:    Sep 14, 2021

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Emert Number:    Z-2475-2021
Emert Status:    Notified