GE SIGNA Architect MRI scanner recalled for liver stiffness errors
GE Medical Systems is recalling a 3.0T SIGNA Architect whole body MRI scanner (System ID 905684MR3T, serial number PG75M2300263SC). Certain protocols can produce incorrect, elevated liver stiffness measurements, which could contribute to inappropriate clinical management decisions. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All GE recalls
What to do
- Check that the scanner's System ID is 905684MR3T and its serial number is PG75M2300263SC.
- Contact GE Medical Systems about this recall. The notice doesn't say what the remedy is.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 3.0T SIGNA Architect, whole body magnetic resonance scanner, System ID 905684MR3T
- 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-0435-2027
In the FDA's words
- Description
- 3.0T SIGNA Architect, whole body magnetic resonance scanner, System ID 905684MR3T Certain protocols can produce incorrect elevated measurements of liver stiffness. These incorrect measurements could contribute to inappropriate clinical management decisions. GTIN: 00840682147095; Serial Number: PG75M2300263SC 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 585214MRAOZ-0434-2027 · 1 unit
- 3.0T SIGNA Architect, whole body magnetic resonance scanner, System ID 905684MR3T (this page)Z-0435-2027 · 1 unit
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ModerateFDANov 4, 2026