Class 2 Device Recall EOS system

• Date Initiated by Firm: February 17, 2015
• Date Posted: May 05, 2015
• Recall Status: Terminated 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: 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