Z-0520-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- October 28, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
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.
Distribution Pattern
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