High FDA (Devices)·Z-2258-2024·Announced 2024-07-10

Prucka 3 Amplifier capacitors could fail during cardiac monitoring procedures

Capacitors in Prucka 3 Amplifiers used with CardioLab and ComboLab cardiac systems could fail, causing display oscillations and preventing visualization of heart electrical activity waveforms.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device used in cardiac monitoring procedures where the potential consequences are significant (loss of critical ECG monitoring data), but no actual injuries or hospitalizations have been reported. This fits the Score 3 criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Medical Systems Information Technologies Inc is recalling the Prucka 3 Amplifier Model #P1801PA and spare part #5875569. These amplifiers are components used with CardioLab AltiX and ComboLab AltiX cardiac recording systems in healthcare settings to record and display heart electrical activity during electrophysiology and hemodynamic monitoring procedures.

Capacitors in the affected amplifiers could fail, resulting in transient oscillations on the display and the inability to view surface and intracardiac electrocardiogram (ECG) waveforms. This malfunction occurs in equipment used to monitor patients during cardiac procedures.

The recall affects approximately 145 units distributed worldwide. In the United States, distribution included Alaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, and Washington. International distribution included Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Republic of Korea, and Singapore.

Facilities with affected equipment should contact GE Medical Systems for corrective actions using the specific serial numbers provided in the recall notice.

The recalled product

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: GE Medical Systems Information Technologies Inc
Category: Medical Device — Cardiac Electrophysiology Recording
Hazard: capacitor-failure
display-oscillation
ecg-monitoring-loss
Affected units: 145

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

SVS23400024SA
SVS23360017SA
SVS23400003SA
SVS23470003SA
SVS23350005SA
SVS23330008SA
SVS23350001SA
SVS23350003SA
SVS23360018SA
SVS23520022SA
SVS23350008SA
SVS23280009SA
SVS23350021SA
SVS23470016SA
SVS23470010SA
SVS23360013SA
SVS23280002SA
SVS23400026SA
SVS23400039SA
SVS23400021SA

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Same manufacturer · GE Medical Systems Information Technologies Inc

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Same hazard · capacitor failure