GE SIGNA Artist MRI recalled for incorrect liver stiffness readings
GE Medical Systems recalled one 1.5T SIGNA Artist whole body MRI scanner (System ID 585214MRAO) because certain protocols can produce incorrect, elevated liver stiffness measurements. These incorrect measurements could contribute to inappropriate clinical management decisions. The notice reports no injuries.
From the FDA notice · Read the official notice ↗ · All GE recalls
What to do
- Contact GE Medical Systems for instructions, since the notice doesn't specify a remedy.
- Identify the affected scanner by System ID 585214MRAO and serial number PG45S2200367SC (GTIN 00195278117021).
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 1.5T SIGNA Artist, whole body magnetic resonance scanner, System ID 585214MRAO
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 1 unit
- Illnesses reported
- None reported
- Manufactured in
- 3200 N Grandview Blvd, Waukesha, Wisconsin, United States
- Classification
- Class II
- Recall number
- Z-0434-2027
In the FDA's words
- Description
- 1.5T SIGNA Artist, whole body magnetic resonance scanner, System ID 585214MRAO Certain protocols can produce incorrect elevated measurements of liver stiffness. These incorrect measurements could contribute to inappropriate clinical management decisions. GTIN: 00195278117021; Serial Number: PG45S2200367SC Distribution: Worldwide - US Nationwide distribution in the states of NY and the country of Canada. Affected quantity: 1 unit
- Hazard
- Certain protocols can produce incorrect elevated measurements of liver stiffness. These incorrect measurements could contribute to inappropriate clinical management decisions.
2 products in this recall
GE SIGNA MRI scanners recalled for incorrect liver stiffness readings
GE recalled two MRI scanners: the 1.5T SIGNA Artist (System ID 585214MRAO) and the 3.0T SIGNA Architect (System ID 905684MR3T), with one unit of each affected. Certain protocols can produce incorrect, elevated liver stiffness measurements, which could contribute to inappropriate clinical management decisions. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- 1.5T SIGNA Artist, whole body magnetic resonance scanner, System ID 585214MRAO (this page)Z-0434-2027 · 1 unit
- 3.0T SIGNA Architect, whole body magnetic resonance scanner, System ID 905684MR3TZ-0435-2027 · 1 unit
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ModerateFDANov 4, 2026