FDAAugust 31, 2016device
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
What to do
FDA enforcement status: Terminated
Brands named
ge healthcare
UPCs
831471837618314019274583151589682
Recall history
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