GE Medical Systems recalls SIGNA PET/MR systems with gradient coils that may produce excessive noise (over 99dB) during scans, exceeding safe hearing protection limits.
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.
GE Medical Systems is recalling SIGNA PET/MR systems that can produce loud acoustic noise during scans. This noise may exceed safe hearing protection limits, potentially causing hearing damage if proper hearing protection isn't used.
Gradient coils in certain SIGNA PET/MR systems can generate acoustic noise exceeding 99dB during scans. This noise level is higher than what hearing protection with a Noise Reduction Rating (NRR) of 29dB can safely manage, potentially causing hearing damage.
Healthcare professionals using SIGNA PET/MR systems with gradient coils are most at risk. Patients using these systems may also be affected if they are sensitive to loud noises.
The recalled product is SIGNA PET/MR systems with the GTIN 00840682105378. Check if your system has gradient coils that may produce elevated acoustic noise during scans.
Ensure hearing protection with a Noise Reduction Rating (NRR) of at least 29dB is used during scans.
No, only SIGNA PET/MR systems with gradient coils that may produce elevated acoustic noise during scans.
Acoustic levels can exceed 99dB during scans, which may exceed safe hearing protection limits.
No, but you must use hearing protection with a Noise Reduction Rating (NRR) of 29dB or higher during scans.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2133-2025 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2133-2025 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
