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U.S. Department of Health and Human Services

Class 2 Device Recall UroDiagnost

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  Class 2 Device Recall UroDiagnost see related information
Date Initiated by Firm July 06, 2009
Date Posted September 24, 2009
Recall Status1 Terminated 3 on December 16, 2011
Recall Number Z-1662-2009
Recall Event ID 53034
Product Classification Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
Product UroDiagnost
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 zero unit distributed in US.
Distribution Worldwide Distribution
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.
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