Z-1460-2015 Class II Terminated
FDA device recall Z-1460-2015 was initiated by Eos Imaging Inc on February 17, 2015 and is designated Class II. Reason for recall: 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 filtrati… The recall status is terminated (terminated May 31, 2017). Affected quantity: 13 units installed in US.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2015
- Initiation Date
- February 17, 2015
- Termination Date
- May 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units installed in US
Product Description
EOS, Digital radiography system used in general radiographic examinations.
Reason for Recall
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.
Distribution Pattern
US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
Code Information
Model Number - EOS System