medical Class II Updated 2022-07-27

GE Healthcare, LLC recalls SIGNA Premier magnetic resonance scanner, model 5748519.

Recalled Product

SIGNA Premier magnetic resonance scanner, model 5748519.


Hazard / Issue

Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: SIGNA Premier GTINs: 00840682135269 and 00195278010797
View official government recall

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