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Recall Observatory FDA recall evidence

Device product

Proteus XR/a (SlOK : K993090)

Z-2449-2019

August 09, 2019

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 83647
Status
Ongoing
Classification
Class II
Quantity
647 US; 167 OUS
Official record key
device-enforcement:Z-2449-2019

Official wording

Reason: Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

Code information: console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)

Distribution pattern: Worldwide - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.