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Recall Observatory FDA recall evidence

Device product

EOS System X- ray beam Digital radiography system used in general radiographic examinations.

Z-0529-2014

November 07, 2013

Class II

Product summary

Firm
EOS Imaging
Event
Event 66833
Status
Terminated
Classification
Class II
Quantity
22 EOS systems are installed in US
Official record key
device-enforcement:Z-0529-2014

Official wording

Reason: EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.

Code information: EOS System

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.