Discovery MR750w 3.0T recall
Discovery MR750w 3.0T, whole body magnetic resonance scanner
Why was Discovery MR750w 3.0T recalled?
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Discovery MR750w 3.0T, whole body magnetic resonance scanner
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 8 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.
- Recall date
- December 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)