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U.S. Department of Health and Human Services

Class 2 Device Recall EOS System

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  Class 2 Device Recall EOS System see related information
Date Initiated by Firm June 19, 2012
Date Posted September 28, 2012
Recall Status1 Terminated 3 on September 16, 2013
Recall Number Z-2072-2012
Recall Event ID 62621
Product Classification Solid state x-ray imager ( flat panel/digital imager) - Product Code MQB
Product EOS X-ray Medical Diagnostic , X-ray Equipment System

Digital Radiography used in general radiographic examination.
Code Information All associated Serial Numbers
Recalling Firm/
Manufacturer		 Eos Imaging Inc
185 Alewife Brook Pkwy Ste 410
Cambridge MA 02138-1104
Manufacturer Reason
for Recall		 It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action EOS Imaging notified users by letter on 6/19/12 and that an on site correction would be performed by an EOS Imaging Field Service engineer. EOS indicated in its notification that although this specific defect has not been observed in EOS systems installed in the U.S, they will replace the anode driver boards with new boards equipped with high current capacitors. Similarly, the generator firmware will be upgraded with the software patch that improves the cooling fans' controls. This will be replaced at no charge to the customers, during regularly scheduled preventative maintenance of the user's EOS system. This should be completed by the end of calendar year 2012. Your proposed CAP appears to adequately address the issues you raised in your notification, and is hereby approved. Your proposed customer notification letter as revised, appears to adequately provide instructions with respect to the use of the product pending the correction of the defect and it appears to provide a clear evaluation in nontechnical terms of the potential hazards related to the defect. Your proposed notification letter is hereby approved for distribution to all affected parties. Further questions please call 678-564-5400.
Quantity in Commerce 12 EOS Systems installed in the US
Distribution Nationwide 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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