{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "133343", "product_res_number": "Z-0346-2016", "event_date_initiated": "2015-02-03", "event_date_created": "2015-12-01", "recall_status": "Terminated", "event_date_terminated": "2017-01-18", "res_event_number": "70370", "product_code": "OWB", "k_numbers": [ "K033737", "K041949", "K130842", "K971365" ], "product_description": "Philips Healthcare Allura Xper Series:\r\nAllura Xper FD10\r\nAllura Xper FD10/10\r\nAllura Xper FD20\r\nAllura Xper FD21\r\nAllura Xper FD22\r\nAllura Xper FD23\r\nAllura Xper FD24\r\nAllura Xper FD25\r\n\r\nProduct Usage:\r\nThe Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures", "code_info": "System : S/N : Model: 722003\t30\tAllura Xper FD10 722010\t670\tAllura Xper FD10 722011\t167\tAllura Xper FD10/10 722012\t1951\tAllura Xper FD20 722012\t536\tAllura Xper FD21 722012\t504\tAllura Xper FD22 722012\t748\tAllura Xper FD23 722012\t536\tAllura Xper FD24 722012\t579\tAllura Xper FD25", "firm_fei_number": "1218950", "recalling_firm": "Philips Medical Systems, Inc.", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "978-687-1501", "reason_for_recall": "Monitor Ceiling Suspension system may fall", "root_cause_description": "Process control", "action": "Philips sent an Urgent Field Safety Notice letter dated January 8, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. The actuator of all affected systems will be replaced free of charge. All affected customers will be contacted in order to schedule the implementation of this action. For questions contact your local Philips representatice: Technical Support Line: 1-800-722-9377.", "product_quantity": "9 units", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.", "openfda": { "k_number": [ "K201583", "K201172", "K223409", "K002198", "K002016", "K152928", "K092439", "K200218", "K093066", "K191503", "K100102", "K142273", "K201743", "K070123", "K121444", "K162614", "K172180", "K133819", "K203281", "K160455", "K260607", "K153232", "K230787", "K010942", "K130893", "K053279", "K220342", "K120282", "K092004", "K000221", "K171755", "K161563", "K233200", "K163140", "K023178", "K151598", "K060259", "K113027", "K170832", "K202431", "K181943", "K240020", "K181830", "K122457", "K232420", "K252068", "K243884", "K172863", "K993687", "K233107", "K170909", "K051064", "K202547", 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