GE Medical Systems, LLC — SIGNA PET/MR
⚠️ GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 23, 2025
Worldwide distribution - US Nationwide and the country of China.
What's affected?
- Product
- SIGNA PET/MR
- Lot code
- GTIN: 00840682105378
Additional details
GTIN: 00840682105378
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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