{"recall":{"id":"fda-device-99865","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Philips North America Llc recalls Philips Medical Systems Technologies Ltd","firm":"Philips North America Llc","date":"2026-08-18","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333","code":"UDI: (01)00884838101111","quantity":"62","number":"Z-3155-2026","classification":"Class II"}],"reason":"The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. and U.S. Territories.","nationwide":false,"states":[],"units":"62","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=99865","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"8cabf6f6484bdc24","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=99865","record":[{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99865","recalling_firm":"Philips North America Llc","address_1":"222 Jacobs St","address_2":"","postal_code":"02141-2289","voluntary_mandated":"FDA Mandated","initial_firm_notification":"","distribution_pattern":"U.S. and U.S. Territories.","recall_number":"Z-3155-2026","product_description":"Philips Medical Systems  Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333","product_quantity":"62","reason_for_recall":"The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.","recall_initiation_date":"20260818","center_classification_date":"20260929","report_date":"20261007","code_info":"UDI: (01)00884838101111","more_code_info":""}]}}