Recall Z-2133-2025 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
SIGNA PET/MR
| Date | Jul 18, 2025 (initiated May 23, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 05/23/2025 delivered using traceable means. The notice explained the issue, risk, and requested the following: Actions to be taken by Customer/User: You can continue to use your MR system by following the instructions below: Ensure hearing protection with a Noise Reduction Rating (NRR) of at least 33dB is used during exams on these systems. 200 pairs are provided with this letter. Please post this letter in your facility on or near the MR operator console. Please ensure all potential users in your facility a |
| Distribution | Worldwide distribution - US Nationwide and the country of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.