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Recall Observatory FDA recall evidence

Device product

EOS, Digital radiography system used in general radiographic examinations.

Z-1460-2015

February 17, 2015

Class II

Product summary

Firm
Eos Imaging Inc
Event
Event 70732
Status
Terminated
Classification
Class II
Quantity
13 units installed in US
Official record key
device-enforcement:Z-1460-2015

Official wording

Reason: When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.

Code information: Model Number - EOS System

Distribution pattern: US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.