FDAAugust 31, 2015device
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biop...
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
002004071306082427270017
Recall history
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- FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24
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