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U.S. Department of Health and Human Services

Class 2 Device Recall Allura Xper FD 10

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 Class 2 Device Recall Allura Xper FD 10see related information
Date Initiated by FirmAugust 24, 2006
Date PostedNovember 08, 2006
Recall Status1 Terminated 3 on May 29, 2008
Recall NumberZ-0162-2007
Recall Event ID 36196
510(K)NumberK041949 
Product Classification x-ray, angiographic system - Product Code IZI
ProductAllura Xper FD 10 x-ray, angiographic system
Code Information Site codes listed in Z-0161-2007 for FD 10/10.
FEI Number 1000524572
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information ContactSarah 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
ActionA 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 Commerce90 total devices - FD 10/10 & FD 10
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZI
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