Class IIDeviceOngoing

Paragonix Technologies Inc.

Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001

Reason for recall

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.

Details

Recall number: Z-2967-2026
Event ID: 99476
Recall initiated: Jul 20, 2026
Classified: Aug 14, 2026
Reported: Aug 26, 2026
Quantity: 1445 systems
Distribution: 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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Braintree, MA, United States
Lot / code info: All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2