Paragonix Technologies Inc. KidneyVault Portable Renal… recallZ-2967-2026 · Paragonix Technologies Inc. · initiated Jul 20, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Paragonix Technologies Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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].
Recall details
- Recall number
- Z-2967-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 20, 2026
- Posted by the FDA
- Aug 14, 2026
- Recalling firm
- Paragonix Technologies Inc.
- Quantity
- 1445 systems
- Product code
- KDN
- FDA submissions
- K234060
- 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.
Product description
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Code information (models, lots, serial numbers)
All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- KidneyVault PRGNX-8008-001Paragonix Technologies Inc · System, Perfusion, Kidney1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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