Recall – Radiographic system not providing audible exposure indication

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

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