FDA-Device2026-08-26Class IIPROCESSING DEFECT
Paragonix KidneyVault Portable Renal Perfusion System recalled for firmware defect causing display loss
What this means
A firmware defect in the KidneyVault datalogger may cause it to lose its configuration, resulting in a blank screen and inability to display organ preservation parameters. This affects 1,445 systems distributed across the US. No injuries have been reported.
- Contact Paragonix Technologies Inc. for a firmware update or replacement device
- Do not rely on the datalogger if the screen is blank; contact the manufacturer immediately
- Check if your system is affected by verifying your device serial number and software version with Paragonix
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
1445 systems
Manufactured in
639 Granite St Ste 408, Braintree, MA, United States
Products
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2967-2026Want us to check the next one for you?
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