{ "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": "93207", "product_res_number": "Z-0012-2011", "event_date_initiated": "2008-08-15", "event_date_posted": "2010-10-06", "recall_status": "Terminated", "event_date_terminated": "2010-10-07", "res_event_number": "49138", "product_code": "KPR", "k_numbers": [ "K070528" ], "product_description": "Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.\n\nIt is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile X-ray table (trolley).\n\nThe intended use is from direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.", "code_info": "Devices were identified as SITE numbers:  553491, 554498, 554944, 553270, 554358, 556089, 556275, 555457, 556080, 557203, 41446107, 41446304, 41443692, 41446097, 41445359, 41445529, 41585399, 41586528, 41796147, 41958550, 42252302, 42616819, and 42865052.", "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": "Customer Care Service Center\n425-487-7602", "reason_for_recall": "When a patient is selected in the patient list and examination tab pressed with background query running at the same time, the wrong patient may be selected.", "root_cause_description": "Other", "action": "Philip Medical System sent an \"URGENT-Device Correction\" letter dated August 13, 2008 to their customers. The letter describes the recalled product as Essenta DR Patient and Image Data Software (SW) release 1.0. The firm informs the customers that when patient is selected in patient list and examination tab pressed with background query running at the same time, there is a risk that the wrong patient is selected on the Essenta DR Computed Radiography System.\n\nCustomers are advised to verify the selected patient's information before releasing an exposure while the firm works on upgrading the Software. All affected units will receive a software upgrade to correct the issue.\n\nCustomers should contact Philips Customer Care Service at 800-772-9377, #5, #4, #1 and reference FCO 712000031 for any questions or support concerning the recall.", "product_quantity": "23 units", "distribution_pattern": "Nationwide distribution: CA, GA, FL, KS, MN, NY, OH, OR, SC, TN, TX, UT, and WA.", "openfda": { "k_number": [ "K110849", "K221853", "K080655", "K181279", "K051258", "K083109", "K181629", "K872525", "K990715", "K231761", "K071430", "K855161", "K201670", "K233662", "K811142", "K811807", "K230241", "K193637", "K102408", "K012546", "K214012", "K781613", "K082798", "K101686", "K902606", "K853330", "K852349", "K936087", "K942792", "K861994", "K945708", "K180663", "K151419", "K990242", "K941592", "K072659", "K942581", "K920347", "K973710", "K233722", "K162529", "K080553", "K163410", "K142049", "K233530", "K162224", "K150816", "K190330", "K921112", "K790685", "K073114", "K121854", "K800564", 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