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).

Reason: 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.

Code information: UDI N/A for the Prucka 3 Amplifier-not a medical device. CardioLab and ComboLab Systems GTIN #00195278507044 and #00195278507051. Prucka 3 Amplifier serial numbers: SVS23400020SA, SVS23400024SA, SVS23360017SA, SVS23400003SA, SVS23470003SA, SVS23350005SA, SVS23330008SA, SVS23350001SA, SVS23350003SA, SVS23360018SA, SVS23520022SA, SVS23350008SA, SVS23280009SA, SVS23350021SA, SVS23470016SA, SVS23470010SA, SVS23360013SA, SVS23280002SA, SVS23400026SA, SVS23400039SA, SVS23400021SA, SVS23330006SA, SVS23360014SA, SVS23360016SA, SVS23460020SA, SVS23470022SA, SVS23480007SA, SVS23360010SA, SVS23350024SA, SVS24020002SA, SVS24020004SA, SVS24020005SA, SVS24020006SA, SVS24020007SA, SVS24020011SA, SVS23460002SA, SVS23350004SA, SVS23350006SA, SVS23350007SA, SVS23480003SA, SVS23400008SA, SVS23210005SA, SVS23360007SA, SVS23360002SA, SVS23360012SA, SVS23470004SA, SVS23520018SA, SVS23520020SA, SVS24020016SA, SVS23460001SA, SVS23470006SA, SVS23470008SA, SVS23350002SA, SVS23350009SA, SVS23350025SA, SVS23360003SA, SVS23360005SA, SVS23360006SA, SVS23360011SA, SVS23400023SA, SVS23400030SA, SVS23400031SA, SVS23400032SA, SVS23400037SA, SVS23400038SA, SVS23460007SA, SVS23400015SA, SVS23350011SA, SVS23350017SA, SVS23470017SA, SVS23470018SA, SVS23470020SA, SVS23460013SA, SVS23460014SA, SVS23480002SA, SVS23480005SA, SVS23480010SA, SVS23480011SA, SVS23480013SA, SVS23480015SA, SVS23520012SA, SVS23280008SA, SVS23290004SA, SVS23330004SA, SVS23350014SA, SVS23350022SA, SVS23350023SA, SVS23460006SA, SVS23400022SA, SVS23350012SA, SVS23350016SA, SVS23480004SA, SVS23470007SA, SVS23400025SA, SVS23460003SA, SVS23460004SA, SVS23350015SA, SVS23320002SA, SVS23470013SA, SVS23350020SA, SVS23330005SA, SVS23470009SA, SVS23470011SA, SVS23470019SA, SVS23470012SA, SVS23460016SA, SVS23290001SA, SVS23350013SA, SVS23460017SA, SVS23480012SA, SVS23480016SA, SVS23330007SA, SVS23360008SA, SVS23360020SA, SVS23400005SA, SVS23400009SA, SVS23400010SA, SVS23400019SA, SVS23460008SA, SVS23280005SA, SVS23400004SA, SVS23460005SA, SVS23400034SA, SVS23400035SA, SVS23400036SA, SVS23400033SA, SVS23400018SA, SVS23470005SA, SVS23400028SA, SVS23400029SA, SVS23360019SA, SVS23400002SA, SVS23360004SA, SVS23400007SA, SVS23400011SA, SVS23400006SA, SVS23350018SA, SVS23330003SA, SVS23290003SA, SVS23290002SA, SVS23330009SA, SVS23350019SA, SVS23360015SA, SVS23470001SA, and SVS23470002SA.

Distribution pattern: 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.