GE Healthcare recalls SIGNA MR355 and MR360 MRI systems due to potential excessive tissue heating during scans if the system resumes scanning after a Power Monitor trip. Affected units have specific system IDs listed in the recall notice.
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 MR355 and MR360 MRI systems because a scan can resume after a Power Monitor trip when the '6-minute average SAR' exceeds the limit. This may cause excessive tissue heating, especially if the patient has conductive materials or implants.
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 the safety limit. This can cause excessive tissue heating, particularly for patients with metal implants or conductive materials.
Healthcare facilities using the recalled SIGNA MR355 and MR360 MRI systems are most at risk. Patients with implants or conductive materials may face increased risk during scans if the system is used without proper safety checks.
Check if your SIGNA MR355 or MR360 system has the specific system IDs listed in the recall notice. The recall includes units with UDI-DI numbers and system IDs provided in the record.
Verify your system's UDI-DI and system IDs against the list provided in the recall notice to confirm if it is affected.
Reach out to GE Healthcare for guidance on next steps if your system is confirmed affected.
The system may incorrectly allow a scan to resume after a Power Monitor trip when the '6-minute average SAR' exceeds the safety limit, potentially causing excessive tissue heating.
Check your system's UDI-DI and system IDs against the list in the recall notice. Contact GE Healthcare for further instructions.
Yes, patients with implants or conductive materials may face increased risk of excessive tissue heating during scans if the system is used without proper safety checks.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1242-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1242-2025 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.
