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U.S. Department of Health and Human Services

Class 2 Device Recall DuoDiagnost

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 Class 2 Recall
DuoDiagnost
see related information
Date Posted March 16, 2012
Recall Status1 Terminated on November 01, 2013
Recall Number Z-1220-2012
Recall Event ID 61007
Premarket Notification
510(K) Number
K983069 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product DuoDiagnost, model 707015, Universal RF system Product Usage: is a mult-functional diagnostic X-Ray system intended for Fluorosopic, Radiographic, Angiographic, and Interventional applications.
Code Information S/N: 07110582 and 09100826
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
The device is currently not compliant with FDA's amended design criteria for this system, the product is not commercially available in the US. However, it was inadvertently shipped to Puerto Rico due to a logistical error.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action Philips sent an Urgent - Field Safety Notice dated December 26, 2011 to the two affected customers. The letter identified the affected product, problem description, hazard involved, actions to be taken by customer/user and actions planned by Philips. The letter states that customers may continue to use the DuoDiagnost system until the new systems are replaced by Philips. A Philips representative will contact customers to arrange for the replacement of current system. For further information or support contact your local Philips representative.
Quantity in Commerce 2 units
Distribution USA Nationwide Distributed in Puerto Rico
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 = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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