Paragonix recalls its KidneyVault Portable Renal Perfusion System (REF# PRGNX-8008-001) due to a firmware defect that may cause a blank screen and loss of preservation parameters. Affected units have specific serial numbers and software versions.
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Paragonix is recalling its KidneyVault Portable Renal Perfusion System because a firmware defect can cause the device to show a blank screen and lose critical preservation settings. This could affect kidney transplant procedures if the device fails during use.
The firmware defect causes the device's datalogger to lose its configuration, which can result in a blank screen and loss of displayed preservation parameters. This may disrupt kidney transplant procedures if the device fails during critical use.
Healthcare professionals using the KidneyVault system for kidney transplants are most at risk. Patients receiving transplants using this device may also be affected if the system malfunctions.
Check for the product name 'KidneyVault Portable Renal Perfusion System' with serial numbers starting with 00850005470342 and software versions 6.1.1 or 6.1.2.
Verify if the device shows a blank screen or loses preservation parameters.
The recall is for healthcare professionals using the device in kidney transplants. If your transplant uses this system, contact Paragonix for guidance.
Check for serial numbers starting with 00850005470342 and software versions 6.1.1 or 6.1.2.
If your device shows a blank screen, stop using it immediately and contact Paragonix for assistance.
We’ve drafted a message you can send Paragonix to request your refund or repair — edit it as you like.
Subject: Recall Z-2967-2026 — Paragonix Paragonix Hello, I own a Paragonix that is covered by recall Z-2967-2026 from Paragonix. 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.
