{"recall":{"id":"fda-device-99730","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v","firm":"Volcano Corp","date":"2026-08-06","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA","code":"UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4","quantity":"19 systems","number":"Z-3276-2026","classification":"Class II"}],"reason":"Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA and the countries of Belgium, Denmark, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom.","nationwide":true,"states":[],"units":"19 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=99730","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a8ddbf84e6c0ba30","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=99730","record":[{"status":"Ongoing","city":"San Diego","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99730","recalling_firm":"Volcano Corp","address_1":"3721 Valley Centre Dr Ste 500","address_2":"","postal_code":"92130-3328","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA and the countries of Belgium, Denmark, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom.","recall_number":"Z-3276-2026","product_description":"Philips IntraSight Plus  REF: 797423 and 797417  100-120v-220-240v,50/60hZ, 1000 VA","product_quantity":"19 systems","reason_for_recall":"Software system  may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.","recall_initiation_date":"20260806","center_classification_date":"20260925","report_date":"20261007","code_info":"UDI:  REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4","more_code_info":""}]}}