FDA Device recall Z-2258-2024
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electroph…
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electroph… by Ge Medical Systems Information Technologies, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2258-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-22 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems Information Technologies |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI N/A for the Prucka 3 Amplifier-not a medical device. CardioLab and ComboLab Systems GTIN #00195278507044 and #001…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, SVS233 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2258-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.