Z-2072-2012 Class II Terminated

Recalled by Eos Imaging Inc — Cambridge, MA

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