{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73599", "product_res_number": "Z-0124-2011", "event_date_initiated": "2008-08-21", "event_date_posted": "2010-10-22", "recall_status": "Terminated", "event_date_terminated": "2010-11-19", "res_event_number": "49488", "product_code": "IZI", "k_numbers": [ "K041949" ], "product_description": "Allura Xper FD10 Monoplane X-ray system.\nIntended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.", "code_info": "Devices are identified with Site Numbers:  14147, 38377, 505254, 544048, 544051, 548067, 549738, 550172, 552470, 552585, 552586, 553234, 553351, 553352, 553925, 554019, 554427, 554431, 554442, 554444, 554550, 554556, 554631, 554745, 554768, 554791, 555206, 556311, 556708, 556783, 557512, 41416358, 41443581, 41443882, 41444662, 41445645, 41446080, 41446144, 41446290, 41446807, 41455906, 41903960, 42393465, 43067304, 43719245, 44048177, and 44604746.", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems North America Co. Phillips", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "Philips Call Center\n425-487-7602", "reason_for_recall": "Due to a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible.", "root_cause_description": "Software design", "action": "Philips Medical Systems North America Co. sent an URGENT - Device Correction, dated September 15, 2010, to their consignees. The letter identified the product, the problem, and the action to be taken. The consignees were informed that there was a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible.\n\nThe consignees were advised that as geometry software errors happen intermittently, no actions can be performed by the consignees to minimize the risk except for not performing DRA procedures until the firm upgrades the software.\n\nFor question consignees were to contact the Philips Call Center at 800-722-9377 #5, #4, #1 and reference FCO 72200111 or FCO 72200125.", "product_quantity": "47 units", "distribution_pattern": "Devices were distributed to hospitals and medical facilities through out the U.S.", "openfda": { "k_number": [ "K941979", "K932410", "K073328", "K955179", "K903373", "K222240", "K970525", "K073290", "K100371", "K042646", "K073088", "K991231", "K903371", "K936002", "K943545", "K910654", "K061871", "K905518", "K113034", "K042961", "K023441", "K052039", "K010721", "K896088", 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"3012939903", "3012470322", "3014262693", "3012883081", "3000126629", "3015231789" ], "device_name": "System, X-Ray, Angiographic", "medical_specialty_description": "Radiology", "regulation_number": "892.1600", "device_class": "2" } } ] }