FDA Medical Device Recalls (openFDA)
Paragonix Technologies Inc.: Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
- Recall number
- Z-2967-2026
- Recalling firm
- Paragonix Technologies Inc.
- Product
- Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
- Status
- Open, Classified
- Initiated
- 2026-07-20
- Posted
- 2026-08-14
- Terminated
- not on file
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2
- 510(k) numbers
- ["K234060"]
- PMA numbers
- not on file
- Product code
- KDN
- Firm FEI
- 3011175555
- Firm city
- Braintree
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28