Recall Z-0529-2014— EOS Imaging
Class II · Terminated
Class II FDA medical device recall by EOS Imaging, initiated 2013-11-07, terminated 2015-01-27. FDA's recall record names no specific 510(k) clearance for this event. Product: EOS System X- ray beam Digital radiography system used in general radiographic examinations.. Reason: 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..
- Recalling firm
- EOS Imaging
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-07
- Terminated
- 2015-01-27
- Firm location
- Paris France, France
Product description
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.