GE Medical Systems, LLC recalls Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVER

Recalled December 4, 2024 · FDA recall Z-0520-2025 · GE Medical Systems

Hazard

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. · FDA Class II

Units

2 units

Sold at

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.

Description

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Product

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,

Manufacturer(s)

GE Medical Systems, LLC

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