Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Check against the official notice below — it lists the full affected range.
Paragonix Technologies Inc. is recalling 1,445 KidneyVault Portable Renal Perfusion Systems nationwide due to a firmware defect in the datalogger component. The defect may cause the datalogger to lose its configuration, resulting in a blank screen and loss of displayed preservation parameters. The affected systems have software versions 6.1.1 or 6.1.2 and UDI 00850005470342.
The systems were distributed across numerous U.S. states and territories including California, Texas, New York, Florida, and many others. The source document does not specify a remedy or recommended action for consumers who have this device.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 1445 systems Lot/code info: All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.