{"url_path":"/fda/device/recalls/Z-2967-2026","section_key":"summary","section_title":"DEVICE Recall: Paragonix Technologies Inc. — Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System  REF# PRGNX-8008-001","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2967-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Paragonix Technologies Inc."},"word_count":129,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2967-2026\n\n**Recalling firm:** Paragonix Technologies Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-20\n**Report date:** 2026-08-26\n\n## Product\nParagonix Technologies Inc. KidneyVault Portable Renal Perfusion System  REF# PRGNX-8008-001\n\n## Reason\nDue 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.\n\n## Affected lots\nAll Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2\n\n## Distribution\nUS 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."}