EOS System X- ray beam Digital radiography system used recall
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Why was EOS System X- ray beam Digital radiography system used recalled?
EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.
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?
EOS System
- Product
- EOS System X- ray beam Digital radiography system used in general radiographic examinations.
- Recalling firm
- EOS Imaging
- Quantity
- 22 EOS systems are installed in US
- Distribution
- Nationwide Distribution
- Recall date
- January 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)