Z-2132-2025 Class II Ongoing
FDA device recall Z-2132-2025 was initiated by GE Medical Systems, LLC on May 23, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: N/A.
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
Discovery MR750w 3.0T
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: 00840682103817 00195278229519