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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 February 06, 2006
Date Posted February 28, 2006
Recall Status1 Terminated 3 on May 20, 2008
Recall Number Z-0582-06
Recall Event ID 34602
510(K)Number K033737  
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Allura Xper FD10 x-ray system
Code Information site numbers provided with the Allura Xper FD10/10
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 lock-up of system requiring reboot of system.
FDA Determined
Cause 2		 Other
Action On 2/6/06 the firm sent a Product Safety Notification letter to the customers that have devices installed. The letter advises of the problem, and to restart the device if it locks up. The letter also states that the firm will be performing upgrades of the devices.
Quantity in Commerce 55 devices total (Allura Xper FD10/10 & Allura Xper FD10)
Distribution Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA.
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, INC.
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