FDA-Device2024-12-04Class II
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
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
2 units
Manufactured in
3200 N Grandview Blvd, Waukesha, WI, United States
Products
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0520-2025More 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief