Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
FDA Recall Z-2967-2026 · Posted 2026-08-14
Advertisement
Recalling FirmParagonix Technologies Inc.
Recall StatusOpen, Classified
Product CodeKDN
Date Initiated2026-07-20
Product Quantity1445 systems
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.
Firm 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 any/all information available on the datalogger screen.
5. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred.
6. Complete and return the enclosed response form by e-mailing a copy to [email protected].
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement