FDAAugust 31, 2015device
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
What to do
FDA enforcement status: Terminated
Brands named
ge healthcare
UPCs
082427110047082427100176082427040149082427010054082427010065082427010069082427010077082427010093082427010095082427070120082427080044082427100228
Recall history
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