Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001 recall
Paragonix Technologies Inc. recalled Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001 on August 26, 2026 because of 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. It was sold nationwide.
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.
What's recalled
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Quantity: 1445 systems
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Paragonix Technologies Inc., Braintree, MA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
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. - Status
- Ongoing
- Recall number
- Z-2967-2026
- Source
- U.S. Food and Drug Administration
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