--- title: "Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model... — FDA record Z-2613-2023 | Is It on Recall" description: "A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become" url: https://isitonrecall.com/recall/fda-device-z-2613-2023-prucka-3-amplifiers-model-p1801pa-and-field-replaceable-units-frus-model-5875569-used-with-cardiolab/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ... — FDA record Z-2613-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Aug 8, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX. - **Reason**: A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable. - **Classification**: Class II - **Recalling firm**: GE Medical Systems Information Technologies Inc - **Quantity**: 81 amplifiers - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2613-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2613-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | GTIN 00195278507044 (CardioLab) and 00195278507051 (ComboLab) Serial numbers for Amplifiers: SVS22330007SA, SVS22330008SA, SVS22330009SA, SVS22330010SA, SVS22330011SA, SVS22330012SA, SVS22330013SA, SVS22330014SA, SVS22330016SA, SVS22330017SA, SVS22330018SA, SVS22330019SA, SVS22330020SA, SVS22330021SA, SVS22330022SA, SVS22330023SA, SVS22330024SA, SVS22330025SA, SVS22330026SA, SVS22330028SA, SVS22330030SA, SVS22330031SA, SVS22330032SA, SVS22330033SA, SVS22330034SA, SVS22330035SA, SVS22440001SA, SVS22440002SA, SVS22440005SA, SVS22440008SA, SVS22440009SA, SVS22440010SA, SVS22440011SA, SVS22440012SA, SVS22440013SA, SVS22440016SA, SVS22490002SA, SVS22490003SA, SVS22490004SA, SVS22520006SA, SVS22520008SA, SVS22520009SA, SVS22520010SA, SVS22520011SA, SVS22520012SA, SVS22520013SA, SVS22520015SA, SVS23040001SA, SVS23040002SA, SVS23040003SA, SVS23040004SA, SVS23040005SA, SVS23040007SA, SVS23040008SA, SVS23040011SA, SVS23040012SA, SVS23040013SA, SVS23040014SA, SVS23040015SA, SVS23040016SA, SVS23040017SA, SVS23040018SA, SVS23040019SA, SVS23070002SA, SVS23070004SA, SVS23070005SA, SVS23070008SA, SVS23070009SA, SVS23070011SA, SVS23070012SA, SVS23100001SA, SVS23100002SA, SVS23100004SA, and SVS23100006SA. Serial numbers for FRUs: SVS22330015SA, SVS22440006SA, SVS22440007SA, SVS22440015SA, SVS22490001SA, SVS22520005SA, and SVS22520014SA. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Distribution was made to CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA, SC, TX, VA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Canada, France, Germany, Greece, Ireland, Japan, Republic of Korea, and Romania. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [Texas](https://isitonrecall.com/state/texas/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) ## Dates in the source - **Report date**: Sep 27, 2023 - **Recall initiation date**: Aug 8, 2023 - **Center classification date**: Sep 19, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2613-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [GE Medical Systems Information Technologies Inc records](https://isitonrecall.com/brand/ge-medical-systems-information-technologies-inc/)