# FDA recall Z-2613-2023

> **GE Medical Systems Information Technologies Inc** · Class II · device recall initiated 2023-08-08.

## 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.

## 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.

## Key facts

- **Recall number:** Z-2613-2023
- **Recalling firm:** GE Medical Systems Information Technologies Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-08
- **Report date:** 2023-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wauwatosa, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2613-2023

## Citation

> AI Analytics. FDA recall Z-2613-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2613-2023. Source: US FDA. Licensed CC0.

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