Reported Jul 10, 2024 · Ongoing
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX…
GE Medical Systems Information Technologies Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems Information Technologies Inc · 9900 W Innovation Dr · Milwaukee, WI · 53226-4856
Is this the product you have?
- 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).
- Lot codes and dates
- 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
145 of 145 codes
SVS23400020SASVS23400024SASVS23360017SASVS23400003SASVS23470003SASVS23350005SASVS23330008SASVS23350001SASVS23350003SASVS23360018SASVS23520022SASVS23350008SASVS23280009SASVS23350021SASVS23470016SASVS23470010SASVS23360013SASVS23280002SASVS23400026SASVS23400039SASVS23400021SASVS23330006SASVS23360014SASVS23360016SASVS23460020SASVS23470022SASVS23480007SASVS23360010SASVS23350024SASVS24020002SASVS24020004SASVS24020005SASVS24020006SASVS24020007SASVS24020011SASVS23460002SASVS23350004SASVS23350006SASVS23350007SASVS23480003SASVS23400008SASVS23210005SASVS23360007SASVS23360002SASVS23360012SASVS23470004SASVS23520018SASVS23520020SASVS24020016SASVS23460001SASVS23470006SASVS23470008SASVS23350002SASVS23350009SASVS23350025SASVS23360003SASVS23360005SASVS23360006SASVS23360011SASVS23400023SA
- Amount recalled
- 145 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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