FDA (Devices) recall action 96311
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE Healthcare's Optima MR360 MRI systems may allow unsafe RF energy exposure if a scan resumes after power loss. The user interface can incorrectly enable scanning when tissue-heating levels exceed safe limits.
GE SIGNA MR380 NMRI systems may allow scans to resume when the 6-minute average SAR (tissue heating rate) exceeds safe limits, potentially causing excessive tissue heating especially in patients with implants or conductive contact.
Certain GE Healthcare MRI systems may incorrectly enable scan resumption when radiofrequency energy absorption exceeds FDA-set limits, potentially causing tissue heating. Risk is higher for patients with implants or touching conductive materials.
GE Healthcare's Brivo MR355 MRI system can incorrectly resume scans when tissue heating limits are exceeded, potentially causing thermal burns if patients contact conductive materials. The recall affects 22 systems distributed nationwide and internationally.
GE Healthcare MRI systems may incorrectly resume scans after power loss when tissue heating rates exceed safe limits, risking excessive heating if patients contact conductive materials or have implants.