United StatesParagonix Technologies Inc. KidneyVault Portable Renal Perfusion System (REF PRGNX-8008-001), all serial numbers/UDI 00850005470342 running Paragonix App software versions 6.1.1 or 6.1.2, 1,445 systems distributed nationwide in the listed US states and territories may be affected. The devices were recalled because a firmware defect can cause the portable organ transfer device datalogger to lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
What's being recalled
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Recalling firm: Paragonix Technologies Inc., Braintree, MA, United States.
How to identify it
All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)