Reported Oct 24, 2018 · Terminated
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE,…
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3200 N Grandview Blvd · Waukesha, WI · 53188-1693
Is this the product you have?
- GE Healthcare MRI Systems, Software Version 12.x
- sold under the following product names
155 of 155 codes
SIGNA MR/I ECHOSPD W/ EXCITE1.5 HISPEED HD 8-CH 400-APMR GOLDSEAL 1.5T HD 8CH USEDUPGRADE 1.5 EXC-II TO EXC-III HDSIGNA MR/I HISPD W/ EXCITE1.5 ECHOSPEED HD 16-CH 800-AP1.5 HISPEED HD 4-CH 200-AP1.5 TWINSPEED HD 8CH-400-APMR UPGRADE LX/HZ TO HD FOR NON LCC1.5 TWINSPEED HD 16CH-800-AP1-5T HDXT TWINSPEED 16 CHANNELSIGNA MR/I TWISP TR W/EXCITE3T HD 16CH-800-AP1.5 ECHOSPEED HD 4-CH 200-APUPGRADE PREEXCITE TO 1.5TS HD 8CHMR GOLDSEAL 1.5T HDXT 16CH NEWMR GOLDSEAL 1.5T HD ES 8CH MOB1-5T NON LCC LX/5_5 TO HDIUPG8CHUPGRADE 1.5 EXC-II TO EXC-III 16HDUPGRADE 1.5 HORIZON TO HS/ES EXCITEUPGRADE FROM 1.5 4X TO HISPEED LX1.5 LX TO HD 8CH FORKLIFT UPGMR GOLDSEAL 1.5 LX HISP PL NEWMR UPGRADE 4X/5X TO HD FOR NON LCCMR GOLDSEAL 1.5 ES+ LXSIGNA HISPEED LX 1.5T FIXED3T HD T/R W/EXCITE1.5 ECHOSPEED HD 8-CH 400-ASIGNA 1.5 ECHOSPEED HD 8-CH 400-ASIGNA EXCITE HD 1.5TMR EXCITE12XMR GOLDSEAL 1.5T HD 8CH USE1.5T BRM ES 16CH 2 VRE FIXED FUPG 1.5 EXC-II TO EXC-III HDEXCITE HD - UPG 3.5 EXC1.5 ECHOSPEED HD 4-CH 200SIGNA HD ADVANCEDEXCITE HD1.5 ECHOSPEED HD 16-CHMR 1.5T HD1.5 ECHOSPEED HD 8-CHMR 1.5 EXCITE HDMR GOLDSEAL 1.5T HD ES 8CH NEW1.5T EXCITE HDSIGNA ECHOSPD LX K4 1.5T FIXED1.5T LX TO 8CH HD 23 UPG1.5 HISPEED HD 8-CSIGNA EXCITE 1.5T HDMR 1.5T HD ECHOSPEED WITH EXCITEMR 1.5T HD TWINSPEMR 1.5T HD ECHOSPEEDMR SIGNA VH/I 3.0TMR 3.0T HD 16CHMR 1.5T HD TWINSPEEDMR 3.0T HD 8CHMR UPG TO 1.5 HDMR UPG TO 1.5T HDMR UPG 1.5ES HD 8CHSIGNA EXCITE HD 1.5 TSIGNA EXCITE HD
- Lot codes and dates
- Model Number
- Serial Number (System ID)
312 of 312 codes
2226300000000000R4938 (256329MR2)2226300000000000R5598 (256ALOPMR)N/AN/A (334699MR)2377062-200000002547YR8 (256265HMR)510784900000274691MR5 (205487MR2)46-294231G10002005-0411-5 (870972E16)46-294231G1002005-1201-35 (623583MR1)2377062-200000963660YM6 (480323MR1)5107849-200000278561MR6 (818445MR)46-294231G1002004-1028-04 (3825)237706200000941225YM5 (626335MR)46-294231G1002004-0913-01 (3591)46-294231G1002005-1018-15 (352333MR3T)N/AN/A (954587MR1)46-294231G1002002-0605-11 (781340MR)5107849266201MR3 (RADNETMR1585)46-294231G1002005-0110-28 (313593MR02)530857300000292781MR2 (609890MR)2214149-200000010224GQ4 (732745MR)2377062-200000963098YM9 (607798MREXCT)N/AN/A (516825MR)N/AN/A (405307NMR)N/AN/A (814535MR1)5107849-200000283624MR5 (615588MRI)N/AN/A (615473MR1)N/AN/A (817922MRLX)5107849-200000278623MR4 (972378NSC3TMR1)46-294231G10002005-0823-7 (DZ1057MR01)46-294231G1002006-0127-10 (DZ1193MR01)222630000000000R5456A (2722SIGNA15)
- Amount recalled
- 5,200 total units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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