Z-2133-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2025
- Initiation Date
- May 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
SIGNA PET/MR
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of China.
Code Information
GTIN: 00840682105378