{"recall":{"id":"fda-device-99476","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Paragonix Technologies Inc. recalls Paragonix Technologies Inc","firm":"Paragonix Technologies Inc.","date":"2026-07-20","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001","code":"All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2","quantity":"1445 systems","number":"Z-2967-2026","classification":"Class II"}],"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"1445 systems","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99476","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c5e27a764b9cb7d3","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99476","record":[{"status":"Ongoing","city":"Braintree","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99476","recalling_firm":"Paragonix Technologies Inc.","address_1":"639 Granite St Ste 408","address_2":"","postal_code":"02184-5369","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-2967-2026","product_description":"Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System  REF# PRGNX-8008-001","product_quantity":"1445 systems","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.","recall_initiation_date":"20260720","center_classification_date":"20260814","report_date":"20260826","code_info":"All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2","more_code_info":""}]}}