GE Medical Systems recalls Prucka 3 Amplifiers (Model P1801PA) and Field Replaceable Units (Model 5875569) used with CardioLab AltiX systems due to potential power supply failure causing inoperability.
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.
GE Medical Systems is recalling Prucka 3 Amplifiers (Model P1801PA) and Field Replaceable Units (Model 5875569) used with CardioLab AltiX and ComboLab AltiX systems. The amplifiers could fail due to overheating in the power supply, causing them to power off and become inoperable.
A diode in the power supply of the amplifier could overheat and fail, causing the device to power off and become inoperable. This could disrupt medical imaging systems and potentially impact patient care if the system is critical for diagnosis or treatment.
Users of medical imaging systems who own the recalled Prucka 3 Amplifiers (Model P1801PA) or Field Replaceable Units (Model 5875569) are affected. Healthcare facilities using these components with CardioLab AltiX or ComboLab AltiX systems are most at risk.
Check for the Prucka 3 Amplifier model P1801PA or Field Replaceable Unit model 5875569 with serial numbers listed in the recall notice. These units were sold with CardioLab AltiX and ComboLab AltiX systems.
Verify if your amplifier or field replaceable unit has a serial number from the list provided in the recall notice.
Reach out to GE Medical Systems for guidance on next steps if your device is affected.
The Prucka 3 Amplifier model P1801PA and Field Replaceable Units (FRUs) model 5875569 are recalled.
Check the serial numbers listed in the recall notice: SVS22330007SA through SVS23100006SA for amplifiers and specific FRU serial numbers for field replaceable units.
The recall does not require immediate stop use; however, affected units should be checked and contacted for guidance.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2613-2023 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2613-2023 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
