GE Healthcare recalls certain SIGNA MR380 MRI systems sold outside the US due to potential excessive tissue heating during scans if the system resumes scanning after a Power Monitor trip when SAR levels exceed limits.
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 specific SIGNA MR380 MRI systems sold outside the US because a scan can resume after a Power Monitor trip when the '6-minute average SAR' exceeds safety limits, potentially causing excessive tissue heating. This risk is especially concerning for patients with implants or conductive materials in contact with the scanning area.
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. This can cause excessive tissue heating, particularly if the patient has an implant or is in contact with conductive materials during the scan.
Healthcare facilities using the recalled SIGNA MR380 MRI systems outside the US are most at risk. Patients undergoing scans with these systems could face excessive tissue heating if the scan resumes incorrectly after a Power Monitor trip.
Check for the SIGNA MR380 system with UDI-DI numbers listed in the recall notice, including the specific system IDs provided in the record. These systems were sold outside the US and are identified by the listed UDI-DI codes.
Verify if your SIGNA MR380 system has a UDI-DI number listed in the provided system IDs to confirm if it's affected.
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.
Check if your system has a UDI-DI number listed in the provided system IDs to confirm if it's affected. If it is, contact GE Healthcare for further instructions.
Yes, patients could experience excessive tissue heating during scans if the system resumes scanning incorrectly after a Power Monitor trip, especially if they have implants or conductive materials in contact with the scanning area.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1243-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1243-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
