medical Class II Updated 2024-12-04

GE Medical Systems, LLC recalls Tomographic Imager Combining Emission Computed Tomography Wi

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) UDI/DI To be provided, System ID 82427070262; 2) UDI/DI To be provided, System ID EX0133
View official government recall

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