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U.S. Department of Health and Human Services

Class 2 Device Recall Practix 160

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  Class 2 Device Recall Practix 160 see related information
Date Initiated by Firm March 23, 2007
Date Posted September 25, 2007
Recall Status1 Terminated 3 on September 16, 2010
Recall Number Z-0763-2007
Recall Event ID 37844
510(K)Number K042368  
Product Classification X-ray systems - Product Code IZL
Product Practix 160 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations.
Code Information Serial Numbers P3-449 and P3-443
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		 X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.
FDA Determined
Cause 2		 Other
Action The firm sent letters out via certified mail from 04/03/2007 through 04/09/2007 to consignees informing them of the issue. The letter indicates that the firm plans to replace consignee's systems with the Practix Convenio Mobile X-ray System at no charge by the end of May 2007.
Quantity in Commerce 2 units
Distribution Nationwide: Distributed to Puerto Rico.
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 = IZL and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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