SIGNA Architect
FDA device recall Z-2130-2025 · posted 2025-07-18 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems, LLC
- 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.
- Action taken
- 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 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.60999@gehealthcare.com.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LNH
- Distribution
- Worldwide distribution - US Nationwide and the country of China.
- Date initiated
- 2025-05-23
- Date posted
- 2025-07-18
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNA Architect (K202966) | Ge Healthcare (Ge Medical Systems, LLC) | 2020-11-13 |
| Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (K163331) | Ge Medical Systems, LLC | 2017-03-17 |
| Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (K160618) | Ge Medical Systems, LLC | 2016-06-09 |