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Recall Observatory FDA recall evidence

Device product

EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.

Z-2072-2012

June 19, 2012

Class II

Product summary

Firm
Eos Imaging Inc
Event
Event 62621
Status
Terminated
Classification
Class II
Quantity
12 EOS Systems installed in the US
Official record key
device-enforcement:Z-2072-2012

Official wording

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.

Code information: All associated Serial Numbers

Distribution pattern: Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.