Company:Philips Medical Systems
Date of Enforcement Report 12/8/2010
Class ll:
PRODUCT
1) Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems. Recall # Z-0124-2011;
2) Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems. Recall # Z-0125-2011
REASON
Potential for table and stand not to move due to a software error.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated September 15, 2010.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
Nationwide