Recall Z-0858-2022— GE Healthcare, LLC

Name: FDA recall Z-0858-2022
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. It names one FDA 510(k) clearance: K041476. Product: 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. 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

510(k) clearances named in this recall

1 on FDA's record

K041476 — GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMGe Medical Systems, LLC·cleared 2004-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. 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.