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).

Class I - Dangerous

🏥 Medical Devices Recalled: April 22, 2024 GE Medical Systems Information Technologies Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: GE Medical Systems Information Technologies Inc
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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).

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2258-2024

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