{ "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": "126535", "product_res_number": "Z-0508-2015", "event_date_initiated": "2014-04-08", "event_date_posted": "2014-12-16", "recall_status": "Terminated", "event_date_terminated": "2018-05-31", "res_event_number": "67869", "product_code": "IZL", "k_numbers": [ "K111725" ], "product_description": "Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.", "code_info": "Serial Numbers: SN12000024, SN12000166\t, SN13000081\t, SN13000127\t, SN13000140\t, SN13000141\t, SN13000143\t, SN13000144\t, SN13000145\t, SN13000167\t, SN13000168\t, SN13000169\t, SN13000196\t, SN13000199\t, SN13000200\t, SN13000201\t, SN13000202\t, SN13000203\t, SN13000204\t, SN13000205\t, SN14000002\t, SN14000004\t, SN14000005\t, SN14000006\t, SN14000008\t, SN14000009\t, SN14000010\t, SN14000011\t, SN14000013\t, SN14000014\t, SN14000015\t, SN14000016\t, SN14000017\t, SN14000019\t, SN14000022\t, SN14000024\t, SN14000026\t, SN14000028\t, SN14000030\t, SN14000031\t, SN14000032\t, SN14000033\t, SN14000038\t, SN14000041\t, SN14000046\t, SN14000047\t, SN14000048\t,  SN13000153\t,  SN13000171\t,  SN13000155\t,  SN13000165\t,  SN13000187\t,  SN13000170\t,  SN13000176\t,  SN13000139\t,  SN13000189\t,  SN7369686\t,  SN13000150\t,  SN13000186\t,  SN13000197\t,  SN13000152\t,  SN13000162\t,  SN13000163\t,  SN14000012\t,  SN11000018\t,  SN13000136\t,  SN13000137\t,  SN13000138\t,  SN13000147\t,  SN13000154\t,  SN13000156\t,  SN13000159\t,  SN13000160\t,  SN13000164\t,  SN13000172\t,  SN13000175\t,  SN13000181\t,  SN13000188\t,  SN13000191\t,  SN13000194\t,  SN14000027\t,  SN130000184\t,  SN13000132\t,  SN13000146\t,  SN13000148\t,  SN13000149\t,  SN13000151\t,  SN13000161\t,  SN13000174\t,  SN13000177\t,  SN13000179\t,  SN13000179\t,  SN13000180\t,  SN13000183\t,  SN13000185\t,  SN13000190\t,  SN13000193\t,  SN13000206\t,  SN14000003\t,  SN14000023\t,  SN14000036\t, SN11000001\t, SN11000002\t, SN11000003\t, SN11000004\t, SN11000005\t, SN11000006\t, SN11000007\t, SN11000008\t, SN11000009\t, SN11000010\t, SN11000011\t, SN11000012\t, SN11000013\t, SN11000014\t, SN11000014\t, SN11000015\t, SN11000016\t, SN11000017\t, SN11000020\t, SN11000021\t, SN11000021\t, SN11000022\t, SN11000023\t, SN11000024\t, SN11000025\t, SN11000026\t, SN11000027\t, SN11000028\t, SN11000029\t, SN11000030\t, SN11000031\t, SN11000032\t, SN11000033\t, SN11000034\t, SN11000035\t, SN11000036\t, SN11000037\t, SN11000039\t, SN11000040\t, SN11000041\t, SN11000042\t, SN11000044\t, SN11000045\t, SN11000046\t, SN11000047\t, SN11000048\t, SN11000048\t, SN11000049\t, SN11000050\t, SN11000051\t, SN11000052\t, SN11000054\t, SN11000055\t, SN11000056\t, SN11000057\t, SN11000058\t, SN11000059\t, SN11000060\t, SN11000061\t, SN11000062\t, SN11000063\t, SN11000064\t, SN11000065\t, SN11000066\t, SN11000067\t, SN11000068\t, SN11000069\t, SN11000070\t, SN11000071\t, SN11000072\t, SN11000073\t, SN11000074\t, SN11000075\t, SN11000076\t, SN11000077\t, SN11000078\t, SN11000079\t, SN11000080\t, SN11000081\t, SN11000082\t, SN11000083\t, SN11000084\t, SN12000002\t, SN12000003\t, SN12000004\t, SN12000005\t, SN12000006\t, SN12000007\t, SN12000008\t, SN12000009\t, SN12000010\t, SN12000012\t, SN12000013\t, SN12000014\t, SN12000015\t, SN12000016\t, SN12000018\t, SN12000019\t, SN12000020\t, SN12000021\t, SN12000022\t, SN12000023\t, SN12000025\t, SN12000026\t, SN12000027\t, SN12000028\t, SN12000029\t, SN12000030\t, SN12000031\t, SN12000032\t, SN12000033\t, SN12000034\t, SN12000035\t, SN12000036\t, SN12000037\t, SN12000038\t, SN12000039\t, SN12000040\t, SN12000041\t, SN12000042\t, SN12000043\t, SN12000044\t, SN12000045\t, SN12000046\t, SN12000047\t, SN12000048\t, SN12000049\t, SN12000050\t, SN12000051\t, SN12000052\t, SN12000053\t, SN12000054\t, SN12000055\t, SN12000056\t, SN12000057\t, SN12000058\t, SN12000059\t, SN12000060\t, SN12000061\t, SN12000062\t, SN12000063\t, SN12000064\t, SN12000065\t, SN12000066\t, SN12000067\t, SN12000068\t, SN12000069\t, SN12000070\t, SN12000071\t, SN12000072\t, SN12000073\t, SN12000074\t, SN12000075\t, SN12000076\t, SN12000077\t, SN12000078\t, SN12000079\t, SN12000080\t, SN12000081\t, SN12000082\t, SN12000083\t, SN12000083\t, SN12000084\t, SN12000085\t, SN12000086\t, SN12000087\t, SN12000088\t, SN12000089\t, SN12000090\t, SN12000091\t, SN12000092\t, SN12000093\t, SN12000094\t, SN12000095\t, SN12000098\t, SN12000099\t, SN12000100\t, SN12000101\t, SN12000102\t, SN12000103\t, SN12000104\t, SN12000105\t, SN12000106\t, SN12000107\t, SN12000108\t, SN12000109\t, SN12000110\t, SN12000111\t, SN12000112\t, SN12000113\t, SN12000114\t, SN12000115\t, SN12000116\t, SN12000117\t, SN12000118\t, SN12000119\t, SN12000120\t, SN12000121\t, SN12000122\t, SN12000123\t, SN12000124\t, SN12000125\t, SN13000001\t, SN13000002\t, SN13000004\t, SN13000005\t, SN13000006\t, SN13000007\t, SN13000008\t, SN13000010\t, SN13000011\t, SN13000012\t, SN13000013\t, SN13000014\t, SN13000015\t, SN13000016\t, SN13000017\t, SN13000018\t, SN13000019\t, SN13000020\t, SN13000021\t, SN13000022\t, SN13000023\t, SN13000025\t, SN13000026\t, SN13000027\t, SN13000028\t, SN13000029\t, SN13000030\t, SN13000031\t, SN13000032\t, SN13000033\t, SN13000034\t, SN13000035\t, SN13000036\t, SN13000037\t, SN13000038\t, SN13000039\t, SN13000040\t, SN13000041\t, SN13000042\t, SN13000043\t, SN13000044\t, SN13000045\t, SN13000046\t, SN13000047\t, SN13000048\t, SN13000049\t, SN13000050\t, SN13000051\t, SN13000052\t, SN13000053\t, SN13000054\t, SN13000055\t, SN13000056\t, SN13000057\t, SN13000058\t, SN13000059\t, SN13000060\t, SN13000061\t, SN13000062\t, SN13000063\t, SN13000064\t, SN13000065\t, SN13000066\t, SN13000067\t, SN13000069\t, SN13000070\t, SN13000071\t, SN13000072\t, SN13000073\t, SN13000074\t, SN13000075\t, SN13000076\t, SN13000077\t, SN13000078\t, SN13000079\t, SN13000080\t, SN13000082\t, SN13000083\t, SN13000084\t, SN13000085\t, SN13000086\t, SN13000087\t, SN13000088\t, SN13000089\t, SN13000090\t, SN13000091\t, SN13000092\t, SN13000093\t, SN13000094\t, SN13000095\t, SN13000096\t, SN13000097\t, SN13000098\t, SN13000099\t, SN13000100\t, SN13000101\t, SN13000102\t, SN13000103\t, SN13000104\t, SN13000105\t, SN13000106\t, SN13000107\t, SN13000108\t, SN13000109\t, SN13000110\t, SN13000111\t, SN13000112\t, SN13000113\t, SN13000114\t, SN13000115\t, SN13000116\t, SN13000117\t, SN13000118\t, SN13000119\t, SN13000120\t, SN13000121\t, SN13000122\t, SN13000123\t, SN13000124\t, SN13000124\t, SN13000125\t, SN13000126\t, SN13000128\t, SN13000129\t, SN13000130\t, SN13000131\t, SN13000133\t, SN13000134\t, SN13000135\t, SN13000157\t, SN13000173\t, SN13000178\t, SN13000182\t, SN13000192\t, SN13000198\t, SN14000007\t, SN14000018\t, SN14000021\t, SN14000025. Four systems were delivered to foreign (non-US) countries that do not have serial numbers.", "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": "Customer Care Solutions\n800-722-9377 Ext. 5", "reason_for_recall": "In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.", "root_cause_description": "Software design", "action": "Philips Healthcare sent an Important Electronic Product Radiation Warning letters dated April 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter alerts customers of the product defect and advises customers of Philips' plan to update the ATP software. A Philips Service Engineer will contact the customer when the Field Action Kit is released for installation. \n\nA customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance.\n\n\nCustomers with questions about this issue can contact their local Philips representative or Philips Healthcare office, or call the Customer Care Solutions Center at 800-722-9377, Option 5. Callers should reference Field Correction Order FCO-71200109.", "product_quantity": "247 in US, 1 in Puerto Rico", "distribution_pattern": "Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI.,and the countries of : Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iraq, Ireland, Italy, Jordan, Liberia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Arab Emirates and United Kingdom.", "openfda": { "k_number": [ "K210982", "K121410", "K813128", "K790392", "K932355", "K012379", "K241505", "K923359", "K032628", "K203782", "K182317", "K202353", "K981466", "K022337", "K173602", "K781030", "K243864", "K234108", "K874840", "K173924", "K944442", "K790451", "K211473", "K151038", "K213405", "K141539", "K202350", "K222258", "K020436", "K833226", "K833239", "K932106", "K122697", "K955095", "K955036", "K211423", "K790393", "K111912", "K241996", "K902984", "K232185", "K973712", "K781705", "K090268", "K221417", "K921425", "K260085", "K912400", "K782155", "K182234", "K071015", "K171353", "K111725", "K251223", "K042361", "K170755", "K141895", "K040046", "K253244", "K043002", "K100400", "K912323", "K781590", "K233678", "K213462", "K203658", "K792665", "K212291", "K052721", "K770903", "K173299", "K201124", "K080701", "K222339", "K183388", "K191025", "K970234", "K930049", "K162278", "K030494", "K222353", "K192936", "K902610", "K850678", "K103522", "K221081", "K891142", "K061685", "K170858", "K142492", "K052001", "K811082", "K911841", "K251443", "K142383", "K843192", "K002685", "K161345", "K122298", "K173187", "K163063", "K260236", "K100449", "K781982", "K043062", "K212515", "K092713", "K083048", "K220678", "K891143", "K162687", "K212654", "K781276", "K042866", "K181874", "K780947", "K781676", "K140723", "K182639", "K953404", "K173018", "K041922", "K945043", "K240841", "K250976", "K143537", "K910902", "K041763", "K010304", "K945707", "K875106", "K162990", "K001517", "K924798", "K790512", "K033238", "K790511", "K802047", "K191884", "K862452", "K932353", "K781975", "K931483", "K082627", "K201340", "K170607", "K941363", "K211383", "K222951", "K181626", "K873982", "K221803", "K072392", "K953292", "K141885", "K931200", "K103476", "K063262", "K193535", "K070634", "K250750", "K241980", "K230581", "K780999", "K253058", "K242515", "K930699", "K780313", "K090655", "K212144", "K973833", "K192011", "K171119", "K052897", "K222896", "K231577", "K220700", "K244049", "K883092", "K183292", "K893637", "K810276", "K890306", "K243473", "K240284", "K032280", "K253185", "K803103", "K153059", "K220175", "K021016", "K212940", "K120062", "K251710", "K894643", "K200726", "K012663", "K781976", "K143494", "K932354", "K080945", "K242015", "K972365", "K062472", "K191813", "K760741", "K240009", "K200976", "K182207", "K934818", "K103597", "K210479", "K921116", "K052341", "K212134", "K191451", "K101517", "K150097", "K781425", "K203667", "K201488", "K042368", "K790443", "K931279", "K250597", "K992229", "K201575", "K200637", "K242651", "K060566", "K213568", "K862118", "K790673", "K894021", "K771571", "K972204", "K090322" ], "registration_number": [ "1418960", "3016250464", "3033527770", "3029916061", "9616047", "9610982", "3006551157", "3009717300", "9614430", "3016674851", "3007734888", "3009077524", "3011015597", "1219183", "3010300212", "3021006193", "3023344919", "3033525986", "3009001657", "3031503890", "3004706313", "8030233", "3015502499", "3024891354", "3018077344", "3025442726", "3011416394", "3015276088", "3008284470", "9615439", "3004606964", "3012127758", "3023003446", "3009715136", "1317307", "3006051164", "3012624817", "3013679558", "3014403439", "3010398867", "3017375271", "3005246977", "3013677815", "3012855798", "3000126629", "3008044777", "3032116890", "3018269927", "9613445", "2433615", "3005810333", "3007836437", "1418964", "3001556265", "3008496839", "3014209556", "2126677", "9617251", "3004977335", "3011950073", "3005877899", "1418484", "3001722928", "3009134655", "3003775006", "1225677", "3003768251", "3013779985", "3007065358", "3004063527", "3014809646", "1222777", "3017944270", "3006542593", "3015537309", "3011491794", "3002707445", "3015223550" ], "fei_number": [ "1418960", "3016250464", "3033527770", "3029916061", "3006551157", "3009717300", "3016674851", "3007734888", "3009077524", "3011015597", "1219183", "3010300212", "3021006193", "3023344919", "3033525986", "3009001657", "3001451453", "3031503890", "3002143662", "3004706313", "3015502499", "3024891354", "3018077344", "3025442726", "3011416394", "3015276088", "3008284470", "3004606964", "3012127758", "3023003446", "3009715136", "1317307", "3006051164", "3012624817", "3013679558", "3014403439", "3010398867", "3017375271", "3005246977", "3013677815", "3012855798", "3000126629", "3008044777", "3002808139", "3032116890", "3018269927", "2433615", "3005810333", "3007836437", "1418964", "3001556265", "3008496839", "3014209556", "2126677", "3003377038", "3002495042", "3004977335", "3011950073", "3005877899", "1418484", "3001722928", "3009134655", "3003775006", "3003768251", "3013779985", "3007065358", "3004063527", "3014809646", "3017944270", "1000120772", "3006542593", "3003861317", "3015537309", "3002175190", "3011491794", "3002707445", "3015223550", "3002807605" ], "device_name": "System, X-Ray, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1720", "device_class": "2" } } ] }