Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SI...
FDA Recall #Z-0520-2025 — Class II — October 28, 2024
Product Description
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
Reason for Recall
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Recalling Firm
GE Medical Systems, LLC — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 units
Distribution
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
Code Information
1) UDI/DI To be provided, System ID 82427070262; 2) UDI/DI To be provided, System ID EX0133
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated