Severity
Moderate
GE Medical Systems, LLC issued this FDA Devices recall on October 24, 2018. Classified as Moderate severity (Class II). Approximately 5,200 total units units are affected. The recall was issued because: The latest on-site software version may not have been reinstalled at some sites after service activities were performed…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
This FDA Devices action (record #Z-0110-2019) was formally reported on October 24, 2018, with the manufacturer initiating the action on June 7, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. GE Medical Systems, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records indicate 5,200 total units units are affected.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) including states of:: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, R…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Severity
Moderate
Units Affected
5,200 total units
Related Recalls
6
6 from same agency
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350), 1.5T SIGNA ECHOSPEED, 1.5T SIGNA EXCITE, 1.5T SIGNA EXCITE MRI, 1.5T SIGNA VIBRANT 16CH FIXED, 3.0T MRI TWINSPEED 8CH, 3.0T SIGNA EXCITE FIXED, 3.0T SIGNA EXCITE UPGRADE, 3T EXCITE, EX ES+8CH USED EXCITE, EXCITE 1.5T, EXCITE 3.0T, EXCITE TWIN, GOLDSEAL 1.5T EXCITE 4CH, GOLDSEAL 1.5T EXCITE 8CH, GOLDSEAL 1.5T EXCITE REL GOLDSEAL EXCITE 1.5T, GOLDSEAL EXCITE 1.5T 8CH, GS 1.5 EX ES+ 4CH NEW, GS 1.5 EX ES+4CH USED, GS 1.5 EX ES+8CH NEW, GS 1.5T EXCITE MRI, GS CLASS 1.5T ES+ EX 4CHN, GS SIGNA EXCITE II 1.5T, GS SIGNA MR/I 1.5T, LCC EXCITE 1.5T, MR 1.5 EX ES 8CH NEW, MR 1.5 EX ES+ 4CH, MR 1.5 EX ES+4CH MOB, MR 1.5 EX ES+8CH, MR 1.5EX8CH, MR 1.5EX8CH USE -HUNG, MR 1.5T EX8CH, MR 1.5T EXCITE 4CH, MR 1.5T EXCITE EXPERT MR, MR 1.5T EXCITE GS, MR 1.5T EXCITE GS MR, MR 1.5T GS ES+ EXCITE 4 CHANNE, MR 1.5T SIGNA EXCITE 8 CH GOLD SEAL, MR 1.5T SIGNA EXCITE II 4CH, MR 3.0T TWINSPEED, MR 3.0T SIGNA EXCI, MR 3.0T SIGNA EXCITE, MR 3.0T SIGNA EXCITE FIXED, MR EXCITE, MR EXCITE 1.5T, MR EXCITE 3, MR EXCITE ECHOSPEE, MR EXCITE ECHOSPEE UPG, MR EXCITE ECHOSPEED, MR EXCITE HISPEED MR EXCITE TWINSPEE, MR EXCITE TWINSPEED, MR GOLD SEAL 1.5 EX ES+8CH NEW, MR GOLDSEAL 1.5 ES PL EX 4 CH, MR GOLDSEAL 1.5 EX, MR GOLDSEAL 1.5 EX, MR GOLDSEAL 1.5 EX 4CH, MR GOLDSEAL 1.5 EX 8CH, MR GOLDSEAL 1.5 EX ES+ 4CH, MR GOLDSEAL 1.5 EX ES+ 4CH NEW, MR GOLDSEAL 1.5 EX ES+4CH, MR GOLDSEAL 1.5 EX ES+4CH USD, MR GOLDSEAL 1.5 EX ES+4CH USE, MR GOLDSEAL 1.5 EX ES+4CH USED, R GOLDSEAL 1.5 EX ES+8CH, MR GOLDSEAL 1.5 EX ES+8CH NEW, MR GOLDSEAL 1.5 EX ES+8CH USED, MR GOLDSEAL 1.5 EXCITE S+ 4CH, MR GOLDSEAL 1.5 FIXED ACTIVE, MR GOLDSEAL 1.5EX4CH NEW -HUNG, MR GOLDSEAL 3.0T EXCITE HD FIX, MR GS 1.5 EX, MR GS 1.5 EX ES+8C, MR GS 1.5 EX ES+8CH, MR SIGNA 1.5 EXCIT, MR SIGNA 1.5 EXCITE EXPERT, MR SIGNA 1.5T EXCITE, MR SIGNA 1.5T EXCITE 4CH MR SIGNA 1.5T EXCITE 8CH, MR SIGNA 1.5T EXCITE 8CH MOBIL, MR SIGNA 1.5T EXCITE EXPERT, MR SIGNA 1.5T EXCITE II, MR SIGNA 15T EXCITE 8CH, MR SIGNA 15T EXCITE 8CH MOBIL, MR SIGNA EXCITE 1.5 T GS (4 CHANNEL, MR SIGNA MR/I ECHOS W/EXCITE, MR SIGNA MR/I ECHOSPD W/ EXCITE, MR SIGNA MR/I ECHOSPD W/ EXCITE , MR SIGNA MR/I ECHOSPEED W/ EXCITE, MR SIGNA MR/I HISPEED W/ EXCITE MR SIGNA MR/I TWISP TR W/EXCIT, MR TWINSPEED 1.5T W/ EXCITE, MR UPG 1.5 SIGNA LX TO EXCITE, MR UPG 3.0T94 ECLIPSE TO EXCIT, MR/I ECHOSPD W/ EXCITE, MR/I ECHOSPEED W/ EXCITE, MR/I SIGNA ECHOSPD W/ EXCITE, MRI EXCITE, MRI EXCITE 1.5T FIXED, MRI SIGNA EXCITE 1.5T, PREOWN 1.5T EXITE, SIGNA 1.5 EXCITE, SIGNA 1.5T , CHOSPEED W EXCITE, SIGNA 1.5T ECHOSPEED W/EXCITE, SIGNA 1.5T ES EXCITE, SIGNA 1.5T EXCITE, SIGNA 1.5T EXCITE 2, SIGNA 1.5T EXCITE EXPERT, SIGNA 1.5T EXCITE II, SIGNA 1.5T SMART SPEED, /EXCITE, SIGNA 1.5T W/ EXCITE, SIGNA 3.0T E, SIGNA 3.0T SIGNA EXCITE FIXED, SIGNA ECHOSPEED 1.5T FIXED, SIGNA ECHOSPEED EXCITE 1.5T, SIGNA ECHOSPEED LX 1.5T FIXED SIGNA ECHOSPEED PLUS + EXCITE, SIGNA EXCITE, SIGNA EXCITE 1.5 SIGNA EXCITE 1.5 T HISPEED, SIGNA EXCITE 1.5T, SIGNA EXCITE 1.5T RELEASE 12.X/MR, SIGNA EXCITE 1.5T SMART SPEED, SIGNA EXCITE 11X, SIGNA EXCITE 3.0T, SIGNA EXCITE ECHOSPEED 1,5 T, SIGNA EXCITE ECHOSPEEED PLUS 1.5 T, SIGNA EXCITE EXPERT 1.5T, SIGNA EXCITE GS 1.5T 4 CHANNEL,SIGNA EXCITE II, SIGNA HISPD LX K4 1.5T FIXED, SIGNA HORIZON LX 1.5T FIXED, SIGNA LX 1.5 EXCITE II., SIGNA LX 1.5T EXCITE, SIGNA LX 1.5T EXCITE II, SIGNA LX1.5T HISPEED, SIGNA MR 1.5 ES EXCITE, SIGNA MR/I 1.5T EXCITE, SIGNA MR/I ECHO W/E,SIGNA MR/I ECHOESPEED W/EXCITE, SIGNA MR/I ECHOSPD, SIGNA MR/I ECHOSPD 1.5T FIXED, SIGNA MR/I ECHOSPD W/ EXCITE 1.5, SIGNA MR/I ECHOSPEED W/ EXCITE, SIGNA MR/I ECHOSPEED W/ EXCITE 1.5T, SIGNA MR/I ECHOSPEED W/EXCITE, SIGNA MR/I ECHOSPEED WITH EXCI, SIGNA MR/I ECHOSPEED WITH EXCITE SIGNA, MR/I
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0110-2019 |
| Date reported | October 24, 2018 |
| Date initiated | June 7, 2018 |
| Recalling firm | GE Medical Systems, LLC |
| Units affected | 5,200 total units |
| Distribution | Worldwide Distribution: US (nationwide) including states of:: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, U… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
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Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
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Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).