TemporaryFDAOngoing
Can cause harm that is usually temporary.
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Check the device or its packaging for
All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2
- Why
- 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.
- Distributed
- US Nationwide distribution in the states and territories of AL, AZ, CA, TN, FL, HI, MN, NJ, TX, UT, CO, CT, DC, MD, GA, KY, LA, MA, MI, MO, MS, NC, ND, NE, NM, NV, NY, PA, PR, SC, UT, VA, WI, WV, IN, OH, KY, IL, MD, MN, OR.
- Company
- Paragonix Technologies Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2967-2026 · retrieved 14 August 2026
Read the official notice