Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Prucka 3 Amplifiers Recalled by GE Medical Systems Information Technologies Inc Due to A diode on the power supply of the...

Date: August 8, 2023
Company: GE Medical Systems Information Technologies Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems Information Technologies Inc directly.

Affected Products

Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.

Quantity: 81 amplifiers

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 17 states: CA, CO, FL, GA, IL, IN, KY, MA, NJ, NC, OH, OR, PA, SC, TX, VA, WI

Affected (17 states)Not affected

About GE Medical Systems Information Technologies Inc

GE Medical Systems Information Technologies Inc has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report