EOS, Digital radiography system used in general radiographic examinations.
Recall
- Recall Number
- Z-1460-2015
- Event Number
- 70732
- Firm
- Eos Imaging Inc
- FEI Number
- 3008632827
- Product Code
- MQB
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- February 17, 2015
- Posted
- May 5, 2015
- Terminated
- May 31, 2017
- Address
- 185 Alewife Brook Pkwy, Ste 410, Cambridge, MA, 02138-1104
Description
EOS, Digital radiography system used in general radiographic examinations.
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.
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.
US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
13 units installed in US