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U.S. Department of Health and Human Services

Class 2 Device Recall Allura Xper FD10

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  Class 2 Device Recall Allura Xper FD10 see related information
Date Initiated by Firm August 21, 2008
Date Posted October 22, 2010
Recall Status1 Terminated 3 on November 19, 2010
Recall Number Z-0124-2011
Recall Event ID 49488
510(K)Number K041949  
Product Classification System, x-ray, angiographic - Product Code IZI
Product 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.
Code Information Devices are identified with Site Numbers:  14147, 38377, 505254, 544048, 544051, 548067, 549738, 550172, 552470, 552585, 552586, 553234, 553351, 553352, 553925, 554019, 554427, 554431, 554442, 554444, 554550, 554556, 554631, 554745, 554768, 554791, 555206, 556311, 556708, 556783, 557512, 41416358, 41443581, 41443882, 41444662, 41445645, 41446080, 41446144, 41446290, 41446807, 41455906, 41903960, 42393465, 43067304, 43719245, 44048177, and 44604746.
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Call Center
425-487-7602
Manufacturer Reason
for Recall		 Due to a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible.
FDA Determined
Cause 2		 Software design
Action Philips Medical Systems North America Co. sent an URGENT - Device Correction, dated September 15, 2010, to their consignees. The letter identified the product, the problem, and the action to be taken. The consignees were informed that there was a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. The consignees were advised that as geometry software errors happen intermittently, no actions can be performed by the consignees to minimize the risk except for not performing DRA procedures until the firm upgrades the software. For question consignees were to contact the Philips Call Center at 800-722-9377 #5, #4, #1 and reference FCO 72200111 or FCO 72200125.
Quantity in Commerce 47 units
Distribution Devices were distributed to hospitals and medical facilities through out the U.S.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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