FDA-Device2020-10-28Class II
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
GE Healthcare, LLC
Hazard
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.
Affected count
N/A
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0131-2021Don'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