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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2258-2024

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).

Publicado el 10 de julio de 2024 · Inicio del retiro: 22 de abril de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Medical Systems Information Technologies Inc
Distribuidor
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.
Lote
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.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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