FDA recall Z-2613-2023

GE Medical Systems Information Technologies Inc · Class II · device

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

Status: Ongoing
Initiation date: 2023-08-08
Report date: 2023-09-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wauwatosa, WI, United States

Primary source

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