Date Initiated by Firm | December 26, 2011 |
Date Posted | March 16, 2012 |
Recall Status1 |
Terminated 3 on November 01, 2013 |
Recall Number | Z-1220-2012 |
Recall Event ID |
61007 |
510(K)Number | K983069 |
Product Classification |
System, x-ray, fluoroscopic, image-intensified - Product Code JAA
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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 MA 01810
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For Additional Information Contact | 978-687-1501 |
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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAA
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