Recall
FDAHealthMay 23, 2025

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.

View original FDA notice →

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