Mar

2013

Cl ll GE Imaging Devices

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll GE Imaging Devices

Amy Sellers

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