Company: Philips Medical Systems, Inc.
Date of Enforcement Report 3/16/2016
Class lI:
PRODUCT
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. Recall Number Z-1066-2016
REASON
Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA on 3/7/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
196 devices
DISTRIBUTION
Nationwide and Canada
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