GE Medical Systems Information Technologies Inc: Device Recall

Recall #Z-2258-2024 · 04/22/2024

Class II: Risk

Recall Details

Recall Number: Z-2258-2024
Classification: Class II
Product Type: Device
Recalling Firm: GE Medical Systems Information Technologies Inc
Status: Ongoing
Date Initiated: 04/22/2024
Location: Milwaukee, WI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 145 units

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.

Product Description

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).

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AK, AZ, CA, CO, FL, GA, IL, KY, MA, ME, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. The countries of Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Republic of Korea, and Singapore.

Other Recalls by GE Medical Systems Information Technologies Inc

Class II: Risk 04/25/2025

The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.

View all recalls by GE Medical Systems Information Technologies Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.