FDAAugust 8, 2023device
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.
What to do
FDA enforcement status: Ongoing
Brands named
ge medical systems information technologies
UPCs
0019527850704400195278507051
Recall history
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