GE Medical Systems recalls SIGNA Architect MRI systems with specific UDI/DI codes due to potential elevated acoustic noise during scans. Affected units may require attention 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 MRI systems because gradient coils can produce loud noises during scans. This risk could cause hearing damage if the noise is not properly managed.
Gradient coils in certain SIGNA Architect MRI systems can generate elevated acoustic noise under specific scanning conditions. This noise may cause hearing damage if not properly managed by trained personnel.
Owners of SIGNA Architect MRI systems with specific UDI/DI codes listed in the recall notice are affected. Medical facilities using these systems are most at risk due to potential hearing damage during scans.
Check for the UDI/DI codes listed in the recall notice, which include specific system IDs and model numbers. The recall covers certain SIGNA Architect MRI systems with the described UDI/DI codes.
Review the system ID on your MRI equipment to see if it matches the listed codes in the recall notice.
Reach out to GE Healthcare for guidance on next steps if your system is affected.
Gradient coils in certain SIGNA Architect MRI systems can produce elevated acoustic noise during scans, which may cause hearing damage.
Check the system ID on your MRI equipment against the list of UDI/DI codes provided in the recall notice.
Contact GE Healthcare for guidance on next steps if your system is affected.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0518-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0518-2025 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.
