Recall Z-0111-2019— GE Medical Systems, LLC

Name: FDA recall Z-0111-2019
Creator: U.S. Food and Drug Administration
Published: 2018-06-07

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2018-06-07, terminated 2020-06-18. It names 6 FDA 510(k) clearances: K052293, K041476, K040444 and 3 more. Product: GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP, 1.5 TWINSPEED HD 8CH-400-AP, MR UPGRADE LX/HZ TO HD FOR NON LCC, 1.5 TWINSPEED HD 16CH-800-AP, 1-5T HDXT TWINSPEED 16 CHANNEL, SIGNA MR/I TWISP TR W/EXCITE, 3T HD 16CH-800-AP, 1.5 ECHOSPEED HD 4-CH 200-AP, UPGRADE PREEXCITE TO 1.5TS HD 8CH, MR GOLDSEAL 1.5T HDXT 16CH NEW, MR GOLDSEAL 1.5T HD ES 8CH MOB, 1-5T NON LCC LX/5_5 TO HDIUPG8CH, UPGRADE 1.5 EXC-II TO EXC-III 16HD, UPGRADE 1.5 HORIZON TO HS/ES EXCITE, UPGRADE FROM 1.5 4X TO HISPEED LX, 1.5 LX TO HD 8CH FORKLIFT UPG., MR GOLDSEAL 1.5 LX HISP PL NEW, MR UPGRADE 4X/5X TO HD FOR NON LCC, MR GOLDSEAL 1.5 ES+ LX, SIGNA HISPEED LX 1.5T FIXED, 3T HD T/R W/EXCITE, 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA EXCITE HD 1.5T, MR EXCITE12X, MR GOLDSEAL 1.5T HD 8CH USE, 1.5T BRM ES 16CH 2 VRE FIXED F, UPG 1.5 EXC-II TO EXC-III HD, EXCITE HD - UPG 3.5 EXC, 1.5 ECHOSPEED HD 4-CH 200, SIGNA HD ADVANCED, EXCITE HD, 1.5 ECHOSPEED HD 16-CH, MR 1.5T HD, 1.5 ECHOSPEED HD 8-CH, MR 1.5 EXCITE HD, MR GOLDSEAL 1.5T HD ES 8CH NEW, 1.5T EXCITE HD, SIGNA ECHOSPD LX K4 1.5T FIXED, 1.5T LX TO 8CH HD 23 UPG, 1.5 HISPEED HD 8-C, SIGNA EXCITE 1.5T HD, MR 1.5T HD ECHOSPEED WITH EXCITE, MR 1.5T HD TWINSPE, MR 1.5T HD ECHOSPEED, MR SIGNA VH/I 3.0T, MR 3.0T HD 16CH, MR 1.5T HD TWINSPEED, MR 3.0T HD 8CH, MR UPG TO 1.5 HD, MR UPG TO 1.5T HD, MR UPG 1.5ES HD 8CH, SIGNA EXCITE HD 1.5 T, SIGNA EXCITE HD, SIGNA MR/I ECHOSPD 1.5T FIX(+75798), SIGNA ES EXCITE, SIGNA 1.5T ECHO HD, MR HD (VON FA. LINK), SIGNA 1.5T ECHOSPEED HD, SIGNA MR 1.5T ECHO HD, SIGNA EXITE-III HD, SIGNA 1.5T HD, ECHOSPEED HD 8-CH, 1.5 ECHOSPEED HD 8CH, MR 1.5T EXCITE HD, MR SIGNA EXCITE 3T HD, MR 1.5 ECHOSPEED HD 8-CH 400-AP, 1.5 ECHOSPEED HD, 1.5T HD, 1.5T HD PREOWN, 1.5T ECHO SPEED, 1.5 ECHOSPEED HD , SIGNA MR 1.5 ECHOSPEED 8CH, SIGNA HD 1.5 ES, MR ECHOSPEED 1.5 HD, SIGNA 1.5TECHOSPEED, MR 1.5 ECHOSPEED HD 8-CH, 1.5T HD EXCITE, SIGNA 1.5 T ECHOSPEED, SIGNA VH/I 3.0T, MR 1.5T HD 16CH, MR 1.5T HD 8CH USED, SIGNA EXCITE3 HD, MR SIGNA EXCITE HD (UPGR.), 1.5T EXCITE-HD, 1.5T EX-HD TWIN, SIGNA 3T, MR 1.5 ECHOSPEED HD 8-CH 400-A, 1.5T EXCITE HD GS, 3T E2, 1.5 ECHOSPEED HD 8-CH 400-, SIGNA EXCITE III HD 1.5T TWIN SPEED, MR GOLDSEAL 1.5T HD 16CH USED, EXCITE II UPG, SIGNA EXCITE III HD 3.0T, MR SIGNA EXCITE, 1.5T SIGNA EXCITE III HD, MR SIGNA HD, SIGNA EXCITE HD 1.5, 3T EXCITE HD, UPG PREEXCITE TO 1.5ES HD 8CH, MR SIGNA SMARTSPEED 1.5, 1.5T HD ECHOSPEED 8 CHANNEL, SIGNA 1.5 MOBILE EXCITE HD, SIGNA 3T HD 16CH-800-AP, SIGNA 3T HD 8CH-400-AP, 1.5T MRI EXCITE 3 UPGRADE, MR 1.5 ECHOSPEED HD 4-CH 200-AP, SIGNA 1.5 ECHOSPEED HD 8-CH 400-AP, SIGNA EXCITE 1.5T ECHOSPEED HD 4CH, MR 3T HD 8CH-400-AP, SIGNA 1.5T ECHOSPEED HD 4-CH 200-AP, 1.5 ECHOSPEED HD 16CH 800AP-2669585, 1.5 ECHOSPEED HD 8-CH 400-AP2669575, 1.5T ECHOSPEED HD16-CH800-AP2669583, UPG 1.5 EXC-II TO EXC-III HD-561936, 1.5 TWINSPEED HD 8CH-400-AP-2583394, 1.5 ECHOSPEED HD 8-CH 400-AP2700482, 1.5 ECHOSPEED HDMR, 1.5 ECHOSPEED HD 8-CH 400-AP EXCITE, MR 1.5 ECHOSPEED HD 8-C, MR SIGNA 1.5T HD 8CH, MR SIGNA 15T HD UPGRADED, MR SIGNA 3T HD 8CH-400-AP, MR SIGNA 1.5T HD UPGRADED, MR SIGNA 1.5T HD 8CH MOBIL, EXCITE HD 1.5T UPGRADES, MR SIGNA EXCITE HD 15T, MR SIGNA EXCITE HD 1.5T, MR 1.5 ECHOSPEED HD 16-CH, MR PROFILE HD PHASE ARRAY, SIGNA 3T EX HD, MR SIGNA VH/I 3.0, MR SIGNA MR/I HISPEED 1.5T, 1.5T ECHOSPEED HD, 1.5 ECHOSPEED HD 8, 1.5T ECHOSPEED HD 8, 1.5 T ECHOSPEED HD 4-CH 200-AP, SIGNA EXCITE 3T HD 8CH-400-AP, MR 1.5T ECHOSPEED HD 8-CH 400-AP, MR 1.5 ECHOSPEED HD 4-CH 200-A, MR/I 1.5 ECHOSPEED HD 4CH 200-, MR 15T ECHOSPEED HD 8-CH 400-, MR 15 ECHOSPEED HD 4-CH 200-A, MR 1.5 ECHOSPEED HD 8-CH 400-AP//, SIGNA 1.5T, SIGNA MR/I ECHOSPD W/ EXCIT, 1.5T EXCITE HD 16 CH, 1.5T HD E. Reason: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-06-07
Terminated: 2020-06-18
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

6 on FDA's record

K052293 — GE 1.5T AND 3.0T SIGNA HDX MR SYSTEMGe Medical Systems, LLC·cleared 2005-09-21
K041476 — GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMGe Medical Systems, LLC·cleared 2004-06-17
K040444 — GE SIGNA 3.0T WITH EXCITE MR SYSTEMGeneral Electric Co.·cleared 2004-04-14
K030874 — GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEMGeneral Electric Co.·cleared 2003-03-28
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

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

GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP, 1.5 TWINSPEED HD 8CH-400-AP, MR UPGRADE LX/HZ TO HD FOR NON LCC, 1.5 TWINSPEED HD 16CH-800-AP, 1-5T HDXT TWINSPEED 16 CHANNEL, SIGNA MR/I TWISP TR W/EXCITE, 3T HD 16CH-800-AP, 1.5 ECHOSPEED HD 4-CH 200-AP, UPGRADE PREEXCITE TO 1.5TS HD 8CH, MR GOLDSEAL 1.5T HDXT 16CH NEW, MR GOLDSEAL 1.5T HD ES 8CH MOB, 1-5T NON LCC LX/5_5 TO HDIUPG8CH, UPGRADE 1.5 EXC-II TO EXC-III 16HD, UPGRADE 1.5 HORIZON TO HS/ES EXCITE, UPGRADE FROM 1.5 4X TO HISPEED LX, 1.5 LX TO HD 8CH FORKLIFT UPG., MR GOLDSEAL 1.5 LX HISP PL NEW, MR UPGRADE 4X/5X TO HD FOR NON LCC, MR GOLDSEAL 1.5 ES+ LX, SIGNA HISPEED LX 1.5T FIXED, 3T HD T/R W/EXCITE, 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA EXCITE HD 1.5T, MR EXCITE12X, MR GOLDSEAL 1.5T HD 8CH USE, 1.5T BRM ES 16CH 2 VRE FIXED F, UPG 1.5 EXC-II TO EXC-III HD, EXCITE HD - UPG 3.5 EXC, 1.5 ECHOSPEED HD 4-CH 200, SIGNA HD ADVANCED, EXCITE HD, 1.5 ECHOSPEED HD 16-CH, MR 1.5T HD, 1.5 ECHOSPEED HD 8-CH, MR 1.5 EXCITE HD, MR GOLDSEAL 1.5T HD ES 8CH NEW, 1.5T EXCITE HD, SIGNA ECHOSPD LX K4 1.5T FIXED, 1.5T LX TO 8CH HD 23 UPG, 1.5 HISPEED HD 8-C, SIGNA EXCITE 1.5T HD, MR 1.5T HD ECHOSPEED WITH EXCITE, MR 1.5T HD TWINSPE, MR 1.5T HD ECHOSPEED, MR SIGNA VH/I 3.0T, MR 3.0T HD 16CH, MR 1.5T HD TWINSPEED, MR 3.0T HD 8CH, MR UPG TO 1.5 HD, MR UPG TO 1.5T HD, MR UPG 1.5ES HD 8CH, SIGNA EXCITE HD 1.5 T, SIGNA EXCITE HD, SIGNA MR/I ECHOSPD 1.5T FIX(+75798), SIGNA ES EXCITE, SIGNA 1.5T ECHO HD, MR HD (VON FA. LINK), SIGNA 1.5T ECHOSPEED HD, SIGNA MR 1.5T ECHO HD, SIGNA EXITE-III HD, SIGNA 1.5T HD, ECHOSPEED HD 8-CH, 1.5 ECHOSPEED HD 8CH, MR 1.5T EXCITE HD, MR SIGNA EXCITE 3T HD, MR 1.5 ECHOSPEED HD 8-CH 400-AP, 1.5 ECHOSPEED HD, 1.5T HD, 1.5T HD PREOWN, 1.5T ECHO SPEED, 1.5 ECHOSPEED HD , SIGNA MR 1.5 ECHOSPEED 8CH, SIGNA HD 1.5 ES, MR ECHOSPEED 1.5 HD, SIGNA 1.5TECHOSPEED, MR 1.5 ECHOSPEED HD 8-CH, 1.5T HD EXCITE, SIGNA 1.5 T ECHOSPEED, SIGNA VH/I 3.0T, MR 1.5T HD 16CH, MR 1.5T HD 8CH USED, SIGNA EXCITE3 HD, MR SIGNA EXCITE HD (UPGR.), 1.5T EXCITE-HD, 1.5T EX-HD TWIN, SIGNA 3T, MR 1.5 ECHOSPEED HD 8-CH 400-A, 1.5T EXCITE HD GS, 3T E2, 1.5 ECHOSPEED HD 8-CH 400-, SIGNA EXCITE III HD 1.5T TWIN SPEED, MR GOLDSEAL 1.5T HD 16CH USED, EXCITE II UPG, SIGNA EXCITE III HD 3.0T, MR SIGNA EXCITE, 1.5T SIGNA EXCITE III HD, MR SIGNA HD, SIGNA EXCITE HD 1.5, 3T EXCITE HD, UPG PREEXCITE TO 1.5ES HD 8CH, MR SIGNA SMARTSPEED 1.5, 1.5T HD ECHOSPEED 8 CHANNEL, SIGNA 1.5 MOBILE EXCITE HD, SIGNA 3T HD 16CH-800-AP, SIGNA 3T HD 8CH-400-AP, 1.5T MRI EXCITE 3 UPGRADE, MR 1.5 ECHOSPEED HD 4-CH 200-AP, SIGNA 1.5 ECHOSPEED HD 8-CH 400-AP, SIGNA EXCITE 1.5T ECHOSPEED HD 4CH, MR 3T HD 8CH-400-AP, SIGNA 1.5T ECHOSPEED HD 4-CH 200-AP, 1.5 ECHOSPEED HD 16CH 800AP-2669585, 1.5 ECHOSPEED HD 8-CH 400-AP2669575, 1.5T ECHOSPEED HD16-CH800-AP2669583, UPG 1.5 EXC-II TO EXC-III HD-561936, 1.5 TWINSPEED HD 8CH-400-AP-2583394, 1.5 ECHOSPEED HD 8-CH 400-AP2700482, 1.5 ECHOSPEED HDMR, 1.5 ECHOSPEED HD 8-CH 400-AP EXCITE, MR 1.5 ECHOSPEED HD 8-C, MR SIGNA 1.5T HD 8CH, MR SIGNA 15T HD UPGRADED, MR SIGNA 3T HD 8CH-400-AP, MR SIGNA 1.5T HD UPGRADED, MR SIGNA 1.5T HD 8CH MOBIL, EXCITE HD 1.5T UPGRADES, MR SIGNA EXCITE HD 15T, MR SIGNA EXCITE HD 1.5T, MR 1.5 ECHOSPEED HD 16-CH, MR PROFILE HD PHASE ARRAY, SIGNA 3T EX HD, MR SIGNA VH/I 3.0, MR SIGNA MR/I HISPEED 1.5T, 1.5T ECHOSPEED HD, 1.5 ECHOSPEED HD 8, 1.5T ECHOSPEED HD 8, 1.5 T ECHOSPEED HD 4-CH 200-AP, SIGNA EXCITE 3T HD 8CH-400-AP, MR 1.5T ECHOSPEED HD 8-CH 400-AP, MR 1.5 ECHOSPEED HD 4-CH 200-A, MR/I 1.5 ECHOSPEED HD 4CH 200-, MR 15T ECHOSPEED HD 8-CH 400-, MR 15 ECHOSPEED HD 4-CH 200-A, MR 1.5 ECHOSPEED HD 8-CH 400-AP//, SIGNA 1.5T, SIGNA MR/I ECHOSPD W/ EXCIT, 1.5T EXCITE HD 16 CH, 1.5T HD E

Reason for recall

The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.

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