Class 2 Device Recall Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System

• Date Initiated by Firm: July 20, 2026
• Date Posted: August 14, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2967-2026
• Recall Event ID: 99476
• 510(K)Number: K234060
• Product Classification: System, perfusion, kidney - Product Code KDN
• Product: Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
• Code Information: All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2
• FEI Number: 3011175555
• Recalling Firm/ Manufacturer: Paragonix Technologies Inc.; 639 Granite St Ste 408; Braintree MA 02184-5369
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDN