{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "199208", "product_res_number": "Z-1382-2023", "event_date_initiated": "2023-03-09", "event_date_posted": "2023-04-12", "recall_status": "Open, Classified", "res_event_number": "91915", "product_code": "KPR", "k_numbers": [ "K163410", "K201725" ], "product_description": "Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy\nModel Number : 712201", "code_info": "UDI-DI: (01)00884838082366(21)\nUS:\nSerial Numbers:\n200072\n200131\n200132\n200143\nSN170053\nSN180074\nSN180163\nSN180181\nSN180182\nSN190119\n\n\nOUS:\n200004\n200005\n200006\n200011\n200014\n200015\n200031\n200039\n200040\n200041\n200043\n200046\n200047\n200048\n200050\n200054\n200058\n200059\n200060\n200061\n200062\n200063\n200064\n200065\n200067\n200068\n200069\n200070\n200072\n200073\n200074\n200075\n200077\n200078\n200079\n200080\n200081\n200082\n200083\n200085\n200087\n200089\n200090\n200091\n200092\n200093\n200095\n200096\n200098\n200099\n200100\n200101\n200102\n200103\n200104\n200105\n200106\n200107\n200108\n200109\n200110\n200112\n200113\n200114\n200115\n200116\n200117\n200118\n200119\n200120\n200121\n200122\n200123\n200124\n200125\n200130\n200131\n200132\n200133\n200134\n200135\n200138\n200141\n200143\n200144\n200146\n200147\n210001\n210003\n210007\n210008\n210009\n210010\n210011\n210013\n210014\n210016\nSN160004\nSN160005\nSN160006\nSN160007\nSN160008\nSN160009\nSN160011\nSN160012\nSN160013\nSN160014\nSN160015\nSN160016\nSN170001\nSN170002\nSN170003\nSN170004\nSN170005\nSN170007\nSN170008\nSN170009\nSN170010\nSN170014\nSN170015\nSN170016\nSN170017\nSN170018\nSN170019\nSN170020\nSN170021\nSN170022\nSN170023\nSN170024\nSN170025\nSN170028\nSN170029\nSN170030\nSN170031\nSN170032\nSN170033\nSN170034\nSN170035\nSN170036\nSN170037\nSN170038\nSN170039\nSN170040\nSN170041\nSN170042\nSN170043\nSN170044\nSN170045\nSN170046\nSN170048\nSN170049\nSN170050\nSN170052\nSN170054\nSN170055\nSN170056\nSN170057\nSN170058\nSN170060\nSN170061\nSN170062\nSN170063\nSN170066\nSN170067\nSN170068\nSN170069\nSN170070\nSN170071\nSN170072\nSN170073\nSN170075\nSN170076\nSN170078\nSN170081\nSN170082\nSN170083\nSN170084\nSN170085\nSN170086\nSN170087\nSN170088\nSN170091\nSN170093\nSN170097\nSN170104\nSN170106\nSN170109\nSN170111\nSN170112\nSN170114\nSN170116\nSN170118\nSN170128\nSN170131\nSN170132\nSN180006\nSN180007\nSN180008\nSN180009\nSN180010\nSN180011\nSN180012\nSN180014\nSN180015\nSN180016\nSN180017\nSN180018\nSN180019\nSN180020\nSN180021\nSN180022\nSN180023\nSN180024\nSN180025\nSN180028\nSN180029\nSN180030\nSN180031\nSN180032\nSN180033\nSN180034\nSN180035\nSN180036\nSN180038\nSN180039\nSN180040\nSN180041\nSN180043\nSN180044\nSN180045\nSN180046\nSN180047\nSN180048\nSN180049\nSN180050\nSN180051\nSN180052\nSN180053\nSN180054\nSN180055\nSN180056\nSN180057\nSN180058\nSN180059\nSN180060\nSN180061\nSN180062\nSN180063\nSN180064\nSN180065\nSN180066\nSN180067\nSN180068\nSN180069\nSN180070\nSN180071\nSN180072\nSN180073\nSN180075\nSN180076\nSN180077\nSN180078\nSN180079\nSN180080\nSN180081\nSN180082\nSN180083\nSN180085\nSN180086\nSN180087\nSN180088\nSN180089\nSN180090\nSN180091\nSN180092\nSN180093\nSN180094\nSN180095\nSN180096\nSN180097\nSN180098\nSN180099\nSN180100\nSN180101\nSN180102\nSN180103\nSN180104\nSN180105\nSN180106\nSN180107\nSN180108\nSN180112\nSN180113\nSN180114\nSN180115\nSN180116\nSN180117\nSN180118\nSN180119\nSN180120\nSN180121\nSN180122\nSN180123\nSN180124\nSN180125\nSN180126\nSN180130\nSN180131\nSN180133\nSN180134\nSN180135\nSN180136\nSN180137\nSN180138\nSN180139\nSN180140\nSN180141\nSN180142\nSN180144\nSN180145\nSN180146\nSN180147\nSN180148\nSN180150\nSN180151\nSN180152\nSN180153\nSN180154\nSN180156\nSN180157\nSN180158\nSN180159\nSN180160\nSN180161\nSN180162\nSN180164\nSN180165\nSN180166\nSN180167\nSN180168\nSN180169\nSN180170\nSN180171\nSN180172\nSN180173\nSN180174\nSN180175\nSN180176\nSN180177\nSN180178\nSN180179\nSN180180\nSN180184\nSN180185\nSN180186\nSN180187\nSN180188\nSN180189\nSN180190\nSN180191\nSN180195\nSN180196\nSN180197\nSN180198\nSN180199\nSN180200\nSN180201\nSN180202\nSN180203\nSN180204\nSN180207\nSN180208\nSN180210\nSN180214\nSN190001\nSN190002\nSN190003\nSN190004\nSN190005\nSN190006\nSN190007\nSN190008\nSN190009\nSN190013\nSN190017\nSN190019\nSN190020\nSN190022\nSN190023\nSN190024\nSN190025\nSN190026\nSN190027\nSN190028\nSN190029\nSN190030\nSN190032\nSN190033\nSN190034\nSN190035\nSN190036\nSN190037\nSN190039\nSN190040\nSN190041\nSN190042\nSN190043\nSN190044\nSN190045\nSN190046\nSN190047\nSN190048\nSN190049\nSN190050\nSN190051\nSN190052\nSN190053\nSN190054\nSN190055\nSN190056\nSN190057\nSN190058\nSN190059\nSN190060\nSN190061\nSN190063\nSN190064\nSN190066\nSN190067\nSN190068\nSN190070\nSN190071\nSN190072\nSN190073\nSN190074\nSN190075\nSN190076\nSN190077\nSN190078\nSN190079\nSN190080\nSN190081\nSN190082\nSN190083\nSN190084\nSN190085\nSN190086\nSN190087\nSN190088\nSN190089\nSN190090\nSN190093\nSN190094\nSN190095\nSN190096\nSN190097\nSN190098\nSN190099\nSN190100\nSN190101\nSN190102\nSN190103\nSN190104\nSN190105\nSN190106\nSN190107\nSN190108\nSN190109\nSN190110\nSN190111\nSN190114\nSN190118\nSN190121\nSN190122\nSN190124\nSN190125\nSN190126\nSN190127\nSN190128\nSN190129\nSN190130\nSN190131\nSN190134\nSN190136\nSN190137\nSN190138\nSN190139\nSN190140\nSN190141\nSN190142\nSN190143\nSN190144\nSN190145\nSN190146\nSN190147\nSN190148\nSN190149\nSN190150\nSN190151\nSN190154\nSN190155\nSN190156\nSN190157\nSN190158\nSN190159\nSN190160\nSN190161\nSN190163\nSN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"firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "additional_info_contact": "Philips Customer Care Solutions Center\n800-722-9377", "reason_for_recall": "If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through\nnormal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users", "root_cause_description": "Equipment maintenance", "action": "Philips issued Urgent Medical Device Correction Letter to US Consignees on 09-Mar-2023.\nLetter states reason for recall, health risk and action to take:\nFollow the Planned Maintenance Program in the Addendum to the Instructions for Use in\nAppendix A of this notice for the safe use of your system(s).\n\" If the Ceiling Suspension is not able to be kept in its current position by itself and descends\nafter the power to the system is off, contact your local Philips representative to perform the\nmaintenance of the telescopic carriage.\n\" Place this URGENT Medical Device Correction Notice with the documentation of your system(s).\n\" Complete the enclosed Customer Reply Form and send it back to confirm that users have reviewed and understood this URGENT Medical Device Correction Notice.\n\nPhilips is informing customers through this URGENT Medical Device Correction Notice and providing\nthe Addendum to the Instructions for Use of the DigitalDiagnost C50 system.\n If you need additional information or support concerning this issue, please contact the Customer Care -9377).", "product_quantity": "US: 10 units; OUS: 570 units", "distribution_pattern": "Nationwide including Puerto Rico 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"3015276088", "3009001657", "3009715136", "3003434037", "3006115340", "3005778458", "3009077524", "3002675731", "2243057", "1418964", "3025442726", "3005172103", "3011416394", "3030089787", "3033525986", "3004977335", "3008364043", "3003775006", "1000114111", "3009134655", "3013714596", "3004989804", "3014209556", "3016674851", "3002885429", "3003202425", "3002808139", "3004077520", "3021059265", "3005116291", "3012127758", "3006165260", "3004756607", "3004485675", "3010300212", "3006051164", "3011955679", "3014293172", "3011015597", "3024891354", "2126677", "3002807880", "3005810333", "2433615", "3009717300", "3014403439", "3009529630", "3016250464", "3023003446", "3001556265", "3007305589", "3011950073", "3012569470", "3029916061", "3004198450", "3042864600", "3001722928" ], "device_name": "System, X-Ray, Stationary", "medical_specialty_description": "Radiology", "regulation_number": "892.1680", "device_class": "2" } } ] }