FDA Medical Device Recalls (openFDA)
Eos Imaging Inc: EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
- Recall number
- Z-2072-2012
- Recalling firm
- Eos Imaging Inc
- Product
- EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
- Status
- Terminated
- Initiated
- 2012-06-19
- Posted
- 2012-09-28
- Terminated
- 2013-09-16
- Reason
- 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.
- Root cause
- 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
- 12 EOS Systems installed in the US
- Distribution
- Nationwide distribution
- Lot, serial or model codes
- All associated Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 3008632827
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28