Date Initiated by Firm | July 06, 2009 |
Date Posted | September 24, 2009 |
Recall Status1 |
Terminated 3 on December 16, 2011 |
Recall Number | Z-1665-2009 |
Recall Event ID |
53034 |
510(K)Number | K982993 |
Product Classification |
Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
|
Product | OmniDiagnost |
Code Information |
N/A |
Recalling Firm/ Manufacturer |
Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell WA 98021-8431
|
For Additional Information Contact | 425-487-7602 |
Manufacturer Reason for Recall | The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
Action | A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009. |
Quantity in Commerce | 28 units |
Distribution | Worldwide Distribution |
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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