Company: GE Healthcare, LLC
Date of Enforcement Report: 10/2/2019
Class II
PRODUCT
Proteus XR/a (SlOK : K993090)
- Recall Number: Z-2449-2019
REASON
Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC on 8/9/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
647 US; 167 OUS
DISTRIBUTION
US Nationwide and International