FDA Medical Device Recalls (openFDA)
Eos Imaging Inc: EOS, Digital radiography system used in general radiographic examinations.
- Recall number
- Z-1460-2015
- Recalling firm
- Eos Imaging Inc
- Product
- EOS, Digital radiography system used in general radiographic examinations.
- Status
- Terminated
- Initiated
- 2015-02-17
- Posted
- 2015-05-05
- Terminated
- 2017-05-31
- Reason
- 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.
- Root 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
- 13 units installed in US
- Distribution
- US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
- Lot, serial or model codes
- Model Number - EOS System
- 510(k) numbers
- ["K123740"]
- 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