GE Healthcare recalls SIGNA Creator and SIGNA Explorer MRI systems with potential risk of excessive tissue heating during scans if a scan resumes after a Power Monitor trip due to high SAR levels. Affected units have specific system IDs; users should check their model and contact GE for remediation.
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
GE Healthcare is recalling certain SIGNA Creator and SIGNA Explorer MRI systems that may resume scans after a Power Monitor trip when the '6-minute average SAR' exceeds safety limits. This could cause excessive tissue heating, especially if the patient is in contact with conductive materials or has implants. The recall is for specific system models with unique identifiers.
The system may incorrectly allow a scan to resume after a Power Monitor trip when the '6-minute average SAR' (a measure of radiation exposure) exceeds safety limits. If the operator resumes scanning without proper safety checks, it can cause excessive tissue heating, particularly for patients with implants or conductive materials.
Patients and medical staff using the affected SIGNA Creator and SIGNA Explorer MRI systems with specific system IDs. Those with implants or conductive materials in contact with the patient are at higher risk during scans.
Check your system's UDI-DI and System ID numbers. Affected units include SIGNA Creator and SIGNA Explorer models with specific system IDs listed in the recall notice (e.g., UDI-DI 00195278577221, System ID MR00160).
Identify your system's UDI-DI and System ID numbers to confirm if it's affected by this recall.
Reach out to GE Healthcare for guidance on next steps and potential remediation.
The system may incorrectly allow a scan to resume after a Power Monitor trip when the '6-minute average SAR' exceeds safety limits, potentially causing excessive tissue heating, especially for patients with implants or conductive materials.
Check your system's UDI-DI and System ID numbers against the list of affected models provided in the recall notice.
No, but you should check your system ID and contact GE Healthcare for guidance on safe use or remediation steps.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1239-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1239-2025 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.
