EOS, Digital radiography system used in general recall
EOS, Digital radiography system used in general radiographic examinations.
Why was EOS, Digital radiography system used in general recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number - EOS System
- Product
- EOS, Digital radiography system used in general radiographic examinations.
- Recalling firm
- Eos Imaging Inc
- Quantity
- 13 units installed in US
- Distribution
- US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
- Recall date
- May 13, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)