Recall Z-2967-2026 ยท KDN System, Perfusion, Kidney
Paragonix Technologies Inc.
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
| Date | Aug 14, 2026 (initiated Jul 20, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | On July 20, 2026, Paragonix Technologies Inc./Getinge issued an Urgent Medical Device Correction to affected consignees via FedEX mail. Paragonix requested consignees to take the following actions: 1. An update to the Paragonix App has been released through the application store. 2. We recommend updating all mobile devices to latest version prior to KidneyVault usage. 3. Please continue to inspect all KidneyVault devices per the IFU before use to ensure proper datalogger function. 4. Continue to follow the IFU for using a multi-faceted clinical approach to assessing the organ, including a |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K234060 | KIDNEYvault Portable Renal Perfusion System Paragonix Technologies, Oct 23, 2024 |