Company:GE Healthcare, LLC
Date of Enforcement Report 3/20/2013
Class ll:

PRODUCT

Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. Z-0935-2013

REASON
An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WA on 5/10/2011. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4026 (1672 US; 2354 OUS)

DISTRIBUTION
Nationwide and Internationally

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