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Paragonix Technologies Inc. recalls Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Recalled August 26, 2026 · FDA recall Z-2967-2026 · Paragonix Technologies
Hazard
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. · FDA Class II
Units
1445 systems
Sold at
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.
Description
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.
Product
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Manufacturer(s)
Paragonix Technologies Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →