FDA-Device2024-12-04Class II
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Hazard
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Sold states
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
Affected count
3 units
Manufactured in
3200 N Grandview Blvd, Waukesha, WI, United States
Products
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0519-2025More GE Medical Systems, LLC recalls
- FDA-Device2026-06-17GE HealthCare Allia IGS 3 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS Pulse X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE HealthCare Allia Moveo X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 5 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 7 Pulse X-ray system recalled for electrical shock risk to service personnel
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