Z-2967-2026Class II

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

Name: Z-2967-2026 Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Creator: Paragonix Technologies Inc.
Published: 2026-07-20
License: https://open.fda.gov/license/

Paragonix Technologies Inc. / initiated 2026-07-20 / Open, Classified / root cause: software

FDA source

Paragonix Technologies Inc. began a recall of Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001 on 2026-07-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2967-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-20
Posted: 2026-08-14
Recalling firm: Paragonix Technologies Inc.
Product: Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Product code: KDN System, Perfusion, Kidney
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.
Root cause tag: software
FDA 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 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].
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.
Product codes and lots: All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2967-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2967-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code KDN

K234060Class IIKIDNEYvault Portable Renal Perfusion SystemParagonix Technologies / cleared 2024-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)