FDAApril 22, 2024device
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).
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
ge medical systems information technologies
UPCs
0019527850704400195278507051
Recall history
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