Recall Z-0519-2025 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
| Date | Nov 22, 2024 (initiated Oct 28, 2024) |
| Status | Open, Classified |
| Reason | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. |
| Root cause | Device Design |
| Action | GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 10/28/20224 delivered through a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken for the continued safe usage of the affected devices: "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 are made aware of this safet |
| Quantity | 3 units |
| Distribution | Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T Ge Medical Systems, LLC, Jun 9, 2016 |
| K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artis Ge Medical Systems, LLC, Mar 17, 2017 |
| K202966 | SIGNA Architect Ge Healthcare (Ge Medical Systems, LLC), Nov 13, 2020 |