Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY
FDA device recall Z-0520-2025 · posted 2024-11-22 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Action taken
- 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 safety notification and the recommended actions. Please retain this document for your records." Please complete and return the attached acknowledgement form to recall.60998@gehealthcare.com. For questions or concerns, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LNH
- Quantity affected
- 2 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.
- Date initiated
- 2024-10-28
- Date posted
- 2024-11-22
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNA PET/MR (K213709) | Ge Medical Systems, LLC | 2022-01-20 |
| SIGNA PET/MR (K163619) | Ge Medical Systems, LLC | 2017-02-14 |
| SIGNA PET/MR (K142098) | Ge Medical Systems, LLC | 2014-11-24 |