Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX… — Class II medical device recall Z-2258-2024
Ongoing recall by GE Medical Systems Information Technologies Inc, reported 2024-07-10, distributed nationwide. Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in trans
| Recall number | Z-2258-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Information Technologies Inc, Milwaukee, WI, United States |
| Recall initiated | 2024-04-22 |
| Classified | 2024-07-03 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CZ, DE, FR, IE, IL, IT, JP, KR, SG |
| Quantity | 145 units |
| UPC / GTIN / UDI-DI | 00195278507044, 00195278507051 |
| Serial numbers | SVS23210005SA, SVS23280002SA, SVS23280005SA, SVS23280008SA, SVS23280009SA, SVS23290001SA, SVS23290002SA, SVS23290003SA, SVS23290004SA, SVS23320002SA, SVS23330003SA, SVS23330004SA, SVS23330005SA, SVS23330006SA, SVS23330007SA, SVS23330008SA, SVS23330009SA, SVS23350001SA, SVS23350002SA, SVS23350003SA, SVS23350004SA, SVS23350005SA, SVS23350006SA, SVS23350007SA, SVS23350008SA and 120 more |
| Model numbers | 5875569, P1801PA |
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2258-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.