GE Medical Systems recalls SIGNA Architect AIR MRI systems with specific UDI codes due to potential elevated acoustic noise during scans. Affected units may require correction to prevent hearing damage.
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
GE Medical Systems is recalling certain SIGNA Architect AIR MRI systems because gradient coils can produce loud noises during scans under specific conditions. This could potentially cause hearing damage if not addressed.
The gradient coils in these MRI systems can generate elevated acoustic noise during scanning under specific conditions. This noise could potentially cause hearing damage if the patient is not protected with appropriate hearing protection.
Medical facilities using the recalled SIGNA Architect AIR MRI systems are most at risk. Patients undergoing scans with these systems may experience hearing damage if the noise is not properly managed.
Check for the UDI/DI codes listed in the recall notice, which include specific system IDs like 82427110161. The affected models were sold between 2023 and 2024.
Identify your system's unique ID from the UDI/DI codes provided in the recall notice.
Reach out to GE Healthcare for guidance on whether your system is affected and next steps.
Check your system's UDI/DI code against the list of affected system IDs provided in the recall notice.
Contact GE Healthcare directly for instructions on how to address the issue.
The recall states that elevated acoustic noise could potentially cause hearing damage, but it does not specify a risk of serious injury.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0519-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0519-2025 from GE Healthcare. 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.
