EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.

FDA device recall Z-2072-2012 · posted 2012-09-28 · Terminated

Recall details

Recalling firm

Eos Imaging Inc

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

MQB

Quantity affected

12 EOS Systems installed in the US

Distribution

Nationwide distribution

Date initiated

2012-06-19

Date posted

2012-09-28

Date terminated

2013-09-16

Location

Cambridge, MA