[Recalled] SIGNA Creator, SIGNA Explorer, NMRI systems — For certain MR systems, a scan can be resumed following a Power Monitor trip wh… | FDA 2025-01-31

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in China and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from GE Healthcare (China) Co., Ltd.

• Brivo MR355, NMRI system — Class II
• GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems — Class II
• GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system — Class II
• GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system — Class II
• GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as: — Class II
• GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.