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U.S. Department of Health and Human Services

Class 2 Device Recall Allura Xper FD 10/10

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  Class 2 Device Recall Allura Xper FD 10/10 see related information
Date Initiated by Firm August 24, 2006
Date Posted November 08, 2006
Recall Status1 Terminated 3 on May 29, 2008
Recall Number Z-0161-2007
Recall Event ID 36196
510(K)Number K041949  
Product Classification x-ray, angiographic system - Product Code IZI
Product Allura Xper FD 10/10 x-ray, angiographic system
Code Information Site numbers for both FD 10/10 and FD 10:  532800, 544506, 543702, 543289, 543209, 543200, 543194, 542714, 542557, 542413, 542117, 542113, 541822, 541592, 541577, 541409, 541029, 541026, 540841, 540488, 540386, 540311, 540301, 540269, 540237, 540235, 540234, 540184, 540070, 540016, 539641, 539628, 539595, 539480, 539455, 539326, 539107, 538903, 538744, 538516, 538514, 538486, 538485, 538476, 538409, 538368, 538157, 538084, 538028, 537855, 537804, 537745, 537698, 537631, 537630, 536966, 536721, 536379, 536138, 536042, 536037, 536035, 536034, 536031, 536028, 535769, 535667, 535416, 535415, 534941, 534731, 534678, 534638, 534634, 533762, 533397, 533289, 533283, 533282, 533278, 532799, 532611, 531942, 530667, 530666, 104497, 103283
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall		 Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.
FDA Determined
Cause 2		 Other
Action A letter dated September 1, 2006 was sent to customers on September 5, 2006. The letter advised customers of the problem and advised a service representative will visit the consignee to install a new software upgrade.
Quantity in Commerce 90 total devices - FD 10/10 & FD 10
Distribution Nationwide.
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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