Recall Z-2967-2026— Paragonix Technologies Inc.
Class II · Ongoing
Class II FDA medical device recall by Paragonix Technologies Inc., initiated 2026-07-20. It names one FDA 510(k) clearance: K234060. Product: Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001. 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..
- Recalling firm
- Paragonix Technologies Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-20
- Firm location
- Braintree, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.