GE Healthcare recalls Optima MR360 MRI systems with potential risk of excessive tissue heating during scans if a Power Monitor trip occurs. 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 Optima MR360 MRI systems due to a risk of excessive tissue heating during scans. This can happen if the system resumes scanning after a Power Monitor trip when the '6-minute average SAR' exceeds safety limits, especially if the patient has conductive materials or implants.
The system may incorrectly allow scanning to resume after a Power Monitor trip when the '6-minute average SAR' exceeds safety limits. This can cause excessive tissue heating, particularly for patients with implants or conductive materials that conduct heat.
MRI system users and healthcare facilities that own the recalled Optima MR360 systems. Patients with implants or conductive materials are at higher risk during scans.
Check for specific system IDs listed in the recall notice: 0910274038, 082427040134, 082427040185, and other model numbers like AE1373MR01, DZ1339MR03, etc. The system was sold with these identifiers between the dates mentioned in the recall.
Identify your system's unique identifier from the list provided in the recall notice.
Reach out to GE Healthcare for further instructions on whether your system is affected and what steps to take.
The system may incorrectly allow scanning to resume after a Power Monitor trip when the '6-minute average SAR' exceeds safety limits, potentially causing excessive tissue heating.
Check your system's unique identifier against the list provided in the recall notice and contact GE Healthcare for further instructions.
The recall states potential excessive tissue heating, but does not specify a risk of serious injury in normal use. The hazard is described as a potential risk, not a guaranteed one.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1241-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1241-2025 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.
