GE Healthcare recalls Brivo MR355 MRI systems with specific serial numbers due to potential excessive tissue heating from scans when SAR levels exceed limits. Affected units may require correction to prevent injury.
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 Brivo MR355 MRI systems because a scan can resume after a power monitor trip when the '6-minute average SAR' exceeds the display limit. This could cause excessive tissue heating, especially if the patient has an implant or is in contact with conductive materials.
The system may incorrectly allow scans to resume after a power monitor trip when the '6-minute average SAR' exceeds the safety limit. If the operator resumes the scan, it can cause excessive tissue heating, particularly for patients with implants or conductive materials in contact with the body.
Patients using the recalled Brivo MR355 MRI systems with specific serial numbers are at risk of excessive tissue heating during scans. Those with medical implants or conductive materials near the scan area are most vulnerable.
Check for the Brivo MR355 MRI system with serial numbers listed in the recall notice, including recent updates. The system IDs are provided in the official recall list.
Identify your Brivo MR355 system's serial number from the list provided in the recall notice.
Reach out to GE Healthcare for guidance on whether your system requires correction to prevent excessive tissue heating.
The system may incorrectly allow scans 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 serial number against the list provided in the recall notice and contact GE Healthcare for guidance on whether correction is needed.
The recall states potential excessive tissue heating, but the remedy does not specify a risk of serious injury. The hazard mechanism requires specific conditions to occur.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1240-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1240-2025 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.
