Z-2449-2019 Class II Ongoing

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
October 2, 2019
Initiation Date
August 9, 2019
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
647 US; 167 OUS

Product Description

Proteus XR/a (SlOK : K993090)

Reason for Recall

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

Distribution Pattern

Worldwide - US Nationwide

Code Information

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