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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 February 17, 2015
Date Posted May 05, 2015
Recall Status1 Terminated 3 on May 31, 2017
Recall Number Z-1460-2015
Recall Event ID 70732
510(K)Number K123740  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product EOS, Digital radiography system used in general radiographic examinations.
Code Information Model Number - EOS System
Recalling Firm/
Manufacturer		 Eos Imaging Inc
185 Alewife Brook Pkwy Ste 410
Cambridge MA 02138-1104
Manufacturer Reason
for Recall		 When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Planned Action of EOS Imaging Inc.: 1. Install a new acquisition software version, which will prevent use of the system when improper filter positioning is detected. 2. A customer notification letter which includes a statement that EOS Imaging will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following CDRH approves the CAP subject to the following conditions: 1. Provide documentation to show that all filter positioning subassemblies have been replaced, which you state was implemented to prevent improper filter positioning. 2. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 3. EOS Imaging will implement this CAP by September 1, 2015. For further questions call (678) 564-5400.
Quantity in Commerce 13 units installed in US
Distribution US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
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.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = EOS IMAGING
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