GE Medical Systems Information Technologies Inc. is recalling 81 Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units, Model 5875569. These devices, used with CardioLab and ComboLab systems, contain a power supply diode that can reach elevated temperatures and fail, causing the amplifier to power off and become completely inoperable. This failure may disrupt medical procedures requiring cardiac monitoring.
A specific component on the circuit board can overheat, leading to a total loss of power to the amplifier during use. If the device fails during a clinical procedure, it could result in a loss of patient monitoring or a delay in treatment while a replacement device is found.
Manufacturer corrective action following notification letter
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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