Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Reported: September 27, 2023 Initiated: August 8, 2023 #Z-2613-2023
Product Description
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.
Details
- Recalling Firm
- GE Medical Systems Information Technologies Inc
- Units Affected
- 81 amplifiers
- 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.
- Location
- Wauwatosa, WI
Frequently Asked Questions
What product was recalled? ▼
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.. Recalled by GE Medical Systems Information Technologies Inc. Units affected: 81 amplifiers.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 27, 2023. Severity: Moderate. Recall number: Z-2613-2023.
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