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U.S. Department of Health and Human Services

Class 2 Device Recall Easy Diagnost Eleva

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 Class 2 Recall
Easy Diagnost Eleva
see related information
Date Posted December 02, 2013
Recall Status1 Open
Recall Number Z-0431-2014
Recall Event ID 66705
Premarket Notification
510(K) Number
K031535 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Easy Diagnost Eleva Universal Fluoroscopic applications
Code Information 706050, 706083, 706088
Recalling Firm/
Manufacturer
Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover, Massachusetts 01810-1032
Manufacturer Reason
for Recall
The delivered application software was an outdated version to the model of equipment.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Medical Systems sent an Urgent - Field Safety Notice dated October 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of its contents. Customers with questions were instructed to contact their Philips representataive: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.
Quantity in Commerce 19 devices
Distribution Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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