GE Healthcare, LLC recalls Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined

Recalled October 28, 2020 · FDA recall Z-0131-2021 · GE Healthcare

Hazard

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. · FDA Class II

Units

N/A

Sold at

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.

Description

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Product

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.

Manufacturer(s)

GE Healthcare, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →