Discovery MR750w MRI Scanner Recalled for Elevated Acoustic Noise
GE Medical Systems is recalling 8 Discovery MR750w 3.0T MRI scanners because their gradient coils can produce elevated acoustic noise during scanning under specific conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall. Elevated acoustic noise during scanning represents a potential hazard with no reported injuries to date. Per the severity rubric, this is classified as High: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Medical Systems, LLC, is recalling 8 Discovery MR750w 3.0T whole-body magnetic resonance scanners. The gradient coils in these systems can produce elevated acoustic noise during scanning operations under specific conditions.
This is a Class II recall issued by the FDA. The affected systems have been distributed worldwide to the United States and 12 other countries: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
The affected systems can be identified using these System IDs: 760724DVMR1, 214820TS750WMR, 281333MR2, 82427240081, 82427120136, 82427200092, 82427250061, and EM0232.
The recalled product
- Product
- Discovery MR750w 3.0T, whole body magnetic resonance scanner
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- acoustic-noise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- System ID 760724DVMR1
- UDI/DI To be provided
- System ID 214820TS750WMR
- System ID 281333MR2
- System ID 82427240081
- UDI/DI (01)00840682103817(11)181200(21)PG75W1800047SC
- System ID 82427120136
- UDI/DI Not Applicable
- System ID 82427200092
- System ID 82427250061
- System ID EM0232
Distribution
Distributed nationwide across the United States.
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