Prucka 3 Amplifiers — Class II medical device recall Z-2613-2023
Ongoing recall by GE Medical Systems Information Technologies Inc, reported 2023-09-27, distributed in CA, CO, FL, GA, IL, IN, KY, MA…. A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevate
| Recall number | Z-2613-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Information Technologies Inc, Wauwatosa, WI, United States |
| Recall initiated | 2023-08-08 |
| Classified | 2023-09-19 |
| Reported by FDA | 2023-09-27 |
| Distributed | CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA, SC, TX, VA, WI |
| Countries outside the US | CA, DE, FR, GR, IE, JP, KR, RO |
| Quantity | 81 amplifiers |
| UPC / GTIN / UDI-DI | 00195278507044, 00195278507051 |
| Model numbers | 5875569, P1801PA |
Product
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Reason for recall
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.
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-2613-2023. 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.