MRI Gradient Coils Produce Excessive Acoustic Noise During Scanning
GE HealthCare is recalling certain SIGNA Architect AIR MRI systems because gradient coils can produce acoustic noise exceeding 99dB during scanning, surpassing safe limits even with required hearing protection.
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 FDA Class II device presents a risk of hearing damage from acoustic noise exposure exceeding established safety limits, even with prescribed hearing protection. No injuries have been reported, which places this in the High category per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
GE HealthCare has identified a safety issue with gradient coils in certain SIGNA Architect AIR magnetic resonance (MRI) systems. Under specific operating conditions, these gradient coils can produce acoustic noise levels that exceed 99dB, which surpasses the safe limit established by the International Electrotechnical Commission (IEC 60601-2-33) standard. The problem occurs even when operators use hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently specified in the device's Operator Manual.
This recall affects MRI systems distributed worldwide, including facilities across the United States and China. Operators and technicians who work with these systems may be exposed to acoustic noise levels that exceed recommended safety thresholds.
Healthcare facilities operating affected SIGNA Architect AIR systems should contact GE HealthCare for guidance on corrective actions or device modifications. No injuries or illnesses have been reported at this time.
The recalled product
- Product
- SIGNA Architect AIR
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- Hazard
- acoustic-noise
- hearing-exposure
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: 00195278283481
Distribution
Distributed nationwide across the United States.
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