{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "160639", "product_res_number": "Z-0311-2018", "event_date_initiated": "2017-07-14", "event_date_created": "2018-01-03", "recall_status": "Terminated", "event_date_terminated": "2020-06-05", "res_event_number": "78833", "product_code": "KPR", "k_numbers": [ "K031535" ], "product_description": "Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.", "code_info": "9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.", "firm_fei_number": "1218950", "recalling_firm": "Philips Electronics North America Corporation", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "Karmen Gruenert\n800-722-9377", "reason_for_recall": "If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.", "root_cause_description": "Under Investigation by firm", "action": "If the lock mechanism of the movable clamp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is\n. applied. This may happen when the detector is rotated clockwise from landscape to portrait position.\nThe Wireless Portable Detector (WPD) is fixed in the Mobile Detector Holder via a lock mechanisrn. The 4 countersunk screws, that are used to attach the lock mechanism, can become loose. If this happens and the mechanism fails, the\ndetector may fall down when the holder is rotated 90 clockwise from Iandscape.", "product_quantity": "412", "distribution_pattern": "412 units affected.", "openfda": { "k_number": [ "K193637", "K102285", "K152767", "K033345", "K981056", "K071430", "K190601", "K012546", "K250954", "K082261", "K833559", "K973710", "K192453", "K201725", "K080614", "K190330", "K953832", "K061595", "K945709", "K904676", "K151924", "K233532", "K180543", "K902378", "K173517", "K910757", "K071401", "K172869", "K942792", "K121513", "K103448", "K811230", "K931071", "K771051", "K870300", "K072659", "K760205", "K250788", "K140326", "K102349", "K220271", "K921539", "K133959", "K101042", "K091752", "K781983", "K082064", "K121345", "K233381", "K202394", "K231995", "K181279", "K942581", "K122589", "K250738", "K800564", "K220518", "K811807", "K083503", "K952871", "K920347", "K913435", "K012389", "K052943", "K201825", "K922813", "K963941", "K062405", "K880982", "K213700", 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"3023190435", "3002808139", "3032116890", "2433615", "3005810333", "3004198450", "1450503", "1418964", "3001556265", "3008496839", "3014209556", "2126677", "3003377038", "3002495042", "3004977335", "3011950073", "2243057", "3013714596", "1418484", "3011955679", "3001722928", "3009134655", "3003775006", "3021059265", "3035950510", "3004989804", "3007305589", "3003768251", "3002885429", "3002807880", "3004485675", "3003434037", "3002175190", "3014293172" ], "device_name": "System, X-Ray, Stationary", "medical_specialty_description": "Radiology", "regulation_number": "892.1680", "device_class": "2" } } ] }