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U.S. Department of Health and Human Services

Class 2 Device Recall OmniDiagnost

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 Class 2 Recall
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Date Posted September 24, 2009
Recall Status1 Open
Recall Number Z-1665-2009
Recall Event ID 53034
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product OmniDiagnost
Code Information N/A
Recalling Firm/
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
Consumer Instructions Contact the recalling firm for information
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: 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

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.