Signa Pet/Mr recallZ-2133-2025 · GE Medical Systems, LLC · initiated May 23, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-2133-2025
- Status
- Open, Classified
- Initiated by the company
- May 23, 2025
- Posted by the FDA
- Jul 18, 2025
- Recalling firm
- GE Medical Systems, LLC
- Product code
- LNH
- Distribution
- Worldwide distribution - US Nationwide and the country of China.
Product description
SIGNA PET/MR
Code information (models, lots, serial numbers)
GTIN: 00840682105378
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA SIGNA PET MRGE Medical Systems, L.L.C. · Tomographic imager combining emission computed tomography with nuclear magnetic resonance11 recalls1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 97030).
- Z-2130-2025 · Open, ClassifiedSIGNA Architect
- Z-2132-2025 · Open, ClassifiedDiscovery MR750w 3.0T
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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