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GE Medical Systems Information Technologies Inc recalls Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemody
Recalled July 10, 2024 · FDA recall Z-2258-2024 · GE Medical Systems Information Technologies
Hazard
Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms. · FDA Class II
Units
145 units
Sold at
Worldwide - US Nationwide distribution in the states of AK, AZ, CA, CO, FL, GA, IL, KY, MA, ME, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. The countries of Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Republic of Korea, and Singapore.
Description
Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.
Product
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ).
Manufacturer(s)
GE Medical Systems Information Technologies Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →