Recall Z-1460-2015 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Eos Imaging Inc
EOS, Digital radiography system used in general radiographic examinations.
| Date | May 5, 2015 (initiated Feb 17, 2015) |
| Status | Terminated |
| 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. |
| Quantity | 13 units installed in US |
| Distribution | US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123740 | EOS Eos Imaging, Feb 22, 2013 |