FDA-Device2023-09-27Class II
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
GE Medical Systems Information Technologies Inc
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.
Sold states
Distribution was made to CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA, SC, TX, VA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Canada, France, Germany, Greece, Ireland, Japan, Republic of Korea, and Romania.
Affected count
81 amplifiers
Manufactured in
9900 Innovation Dr, Wauwatosa, WI, United States
Products
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2613-2023Don't want to check this manually?
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