Company: Philips Medical Systems, Inc.
Date of Enforcement Report 11/19/2014
Class lI:
PRODUCT
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Recall Number Z-0181-2015
REASON
Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc ,Andover, MA on 7/8/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
22 systems
DISTRIBUTION
Nationwide and Internationally
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