Recall Z-0859-2022— GE Healthcare, LLC

Name: FDA recall Z-0859-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-18

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-02-18. FDA's recall record names no specific 510(k) clearance for this event. Product: SIGNA Excite 3T. Magnetic Resonance Imaging System. Reason: There is potential for the images to be flipped left to right..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-02-18
Firm location: Waukesha, WI, United States

Product description

SIGNA Excite 3T. Magnetic Resonance Imaging System

Reason for recall

There is potential for the images to be flipped left to right.

Data sourced from openFDA. This site is unofficial and independent of the FDA.