Recall Z-2072-2012— Eos Imaging Inc
Class II · Terminated
Class II FDA medical device recall by Eos Imaging Inc, initiated 2012-06-19, terminated 2013-09-16. FDA's recall record names no specific 510(k) clearance for this event. Product: EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.. Reason: It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode..
- Recalling firm
- Eos Imaging Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-19
- Terminated
- 2013-09-16
- Firm location
- Cambridge, MA, United States
Product description
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Reason for recall
It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.
Data sourced from openFDA. This site is unofficial and independent of the FDA.