SIGNA PET/MR gradient coils produce excessive acoustic noise during scanning
GE Medical Systems recalled SIGNA PET/MR imaging systems because gradient coils produce acoustic noise exceeding 99 decibels during scanning, surpassing established safety limits even with 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 is classified as High severity (Score 3) under the rubric criterion for 'risk-of-harm products where injury has not yet been reported.' The gradient coils produce acoustic noise exceeding 99dB (the IEC 60601-2-33 safety limit), posing a hearing damage risk, though no illnesses or injuries have been reported.
Plain-English summary
GE Medical Systems, LLC has recalled SIGNA PET/MR imaging systems. The systems are distributed worldwide, including in the US and China. The recall was issued because gradient coils in these systems can produce elevated acoustic noise during scanning operations.
Under certain conditions, the acoustic noise from the gradient coils can exceed 99 decibels. This level exceeds the safety limit established by the International Electrotechnical Commission (IEC 60601-2-33) standard when using hearing protection with a Noise Reduction Rating of 29 decibels, as currently specified in the system's Operator Manual.
Facility operators and healthcare workers should contact GE Medical Systems for guidance on remediation. The manufacturer will provide further information to address this acoustic safety concern in affected systems.
The recalled product
- Product
- SIGNA PET/MR
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- acoustic-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: 00840682105378
Distribution
Distributed nationwide across the United States.
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