GE Discovery MR750w MRI System Gradient Coil Acoustic Noise Hazard
GE HealthCare's Discovery MR750w 3.0T MRI systems can produce excessive acoustic noise from gradient coils during scanning, potentially exceeding safe hearing protection limits.
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: This is an FDA Class II medical device recall with no reported injuries or illnesses. The hazard is theoretical risk of hearing damage from acoustic noise exceeding the established International Electrotechnical Commission safety standard, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE HealthCare has identified a safety issue with the Discovery MR750w 3.0T MRI system. The gradient coils within these systems can produce elevated acoustic noise during scanning operations under certain conditions.
Acoustic noise levels from these gradient coils can exceed 99 decibels, surpassing the 99dB limit established by the International Electrotechnical Commission standard IEC 60601-2-33. The standard applies when using hearing protection with a Noise Reduction Rating of 29dB, as specified in the Operator Manual.
The affected Discovery MR750w 3.0T systems have been distributed worldwide, including throughout the United States and China.
The recalled product
- Product
- Discovery MR750w 3.0T
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- Hazard
- excessive-noise
- hearing-damage
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 (1)
- GTIN: 00840682103817 00195278229519
Distribution
Distributed nationwide across the United States.
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