Z-0517-2025 Class II Ongoing
FDA device recall Z-0517-2025 was initiated by GE Medical Systems, LLC on October 28, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 8 units.
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
- 8 units
Product Description
Discovery MR750w 3.0T, whole body magnetic resonance scanner
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
System ID 760724DVMR1, UDI/DI To be provided; System ID 214820TS750WMR, UDI/DI To be provided; System ID 281333MR2, UDI/DI To be provided; System ID 82427240081, UDI/DI (01)00840682103817(11)181200(21)PG75W1800047SC; System ID 82427120136, UDI/DI Not Applicable; System ID 82427200092, UDI/DI To be provided; System ID 82427250061, UDI/DI To be provided; System ID EM0232, UDI/DI Not Applicable