FDA-Device2019-10-02Class II

Proteus XR/a (SlOK : K993090)

GE Healthcare, LLC
Hazard

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

Sold states
Worldwide - US Nationwide
Affected count
647 US; 167 OUS
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Proteus XR/a (SlOK : K993090)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2449-2019

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