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

FDA device recall Z-2967-2026 · posted 2026-08-14 · Open, Classified

Recall details

Recalling firm: Paragonix Technologies Inc.
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.
Action taken: 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 recallresponses.qrc@getinge.com.
Root cause: Software design
Status: Open, Classified
Product code: KDN
Quantity affected: 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,
Date initiated: 2026-07-20
Date posted: 2026-08-14
Location: Braintree, MA

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Related 510(k) clearances

Record	Firm	Date
KIDNEYvault Portable Renal Perfusion System (K234060)	Paragonix Technologies	2024-10-23