Recall Z-0693-2019— GE Healthcare, LLC

Name: FDA recall Z-0693-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-15

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-11-15, terminated 2021-01-17. It names 6 FDA 510(k) clearances: K121676, K053009, K033504 and 3 more. Product: Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use. Reason: Possible incorrect software version loaded..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-11-15
Terminated: 2021-01-17
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

6 on FDA's record

K121676 — 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTGe Medical Systems, LLC·cleared 2012-09-20
K053009 — GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEMGE Medical Systems·cleared 2005-11-17
K033504 — GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEMGeneral Electric Co.·cleared 2003-11-25
K013636 — SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGYGE Medical Systems·cleared 2002-01-24
K012200 — 1.5T INFINITY TWINSPEED MR SYSTEMGE Medical Systems·cleared 2001-08-03
K992746 — SIGNA HFO/I MAGNETIC RESONANCE SYSTEMGe Medical Systems, Inc.·cleared 1999-11-09

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

Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

Reason for recall

Possible incorrect software version loaded.

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