{"recall":{"id":"fda-device-99511","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT with software V4","firm":"Philips Healthcare (Suzhou) Co., Ltd.","date":"2026-06-26","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.","code":"Device Identifier: (01)00884838085015, (01)00884838105508.","quantity":"N/A","number":"Z-2988-2026","classification":"Class II"}],"reason":"Potential of failing to trigger clinical scan during Bolus Tracking.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide and U.S. Territories distribution.","nationwide":true,"states":[],"units":"N/A","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as fda mandated; 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=99511","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ba21bd7bfa9453ac","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=99511","record":[{"status":"Ongoing","city":"Suzhou","state":"N/A","country":"China","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99511","recalling_firm":"Philips Healthcare (Suzhou) Co., Ltd.","address_1":"Suzhou Industrial Park","address_2":"No. 258 Zhongyuan Road; Pingjiang","postal_code":"N/A","voluntary_mandated":"FDA Mandated","initial_firm_notification":"N/A","distribution_pattern":"U.S. Nationwide and U.S. Territories distribution.","recall_number":"Z-2988-2026","product_description":"Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.","product_quantity":"N/A","reason_for_recall":"Potential of failing to trigger clinical scan during Bolus Tracking.","recall_initiation_date":"20260626","center_classification_date":"20260821","report_date":"20260902","code_info":"Device Identifier: (01)00884838085015, (01)00884838105508."}]}}