SIGNA PET/MR gradient coils can produce acoustic noise above the limit
GE HealthCare SIGNA PET/MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
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: Risk-of-harm product: acoustic exposure above the international safety limit for patients undergoing a scan, with no injury reported in the source.
Plain-English summary
The SIGNA PET/MR system from GE HealthCare, GTIN 00840682105378, is being recalled. The source does not state a quantity.
According to GE HealthCare, gradient coils for certain MR systems can, under specific conditions, produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99 dB, the limit established by International Electrotechnical Commission standard IEC 60601-2-33 when using hearing protection with a Noise Reduction Rating of 29 dB, as currently required in the operator manual. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including nationwide in the United States and to China. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the manufacturer's affected product list and follow the instructions issued by GE HealthCare.
The recalled product
- Product
- SIGNA PET/MR
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — PET/MR system
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.
Part of a larger recall action
This product is one of 4 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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