Z-2072-2012 Class II Terminated
FDA device recall Z-2072-2012 was initiated by Eos Imaging Inc on June 19, 2012 and is designated Class II. 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. The recall status is terminated (terminated September 16, 2013). Affected quantity: 12 EOS Systems installed in the US.
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2012
- Initiation Date
- June 19, 2012
- Termination Date
- September 16, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 EOS Systems installed in the US
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.
Distribution Pattern
Nationwide distribution
Code Information
All associated Serial Numbers