{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215163", "product_res_number": "Z-2239-2025", "event_date_initiated": "2025-07-17", "event_date_posted": "2025-08-01", "recall_status": "Open, Classified", "res_event_number": "97309", "product_code": "MUJ", "k_numbers": [ "K170086" ], "product_description": "Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software", "code_info": "Software Version Number: 18.0.5/UDI: (01)00884838103566", "firm_fei_number": "3018004899", "recalling_firm": "Philips Medical Systems (Cleveland) Inc", "address_1": "3630 Sw 47th Ave", "city": "Gainesville", "state": "FL", "postal_code": "32608-7555", "additional_info_contact": "Philips Customer Care Center\n1800-722-9377", "reason_for_recall": "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the \"Stopping Power Ratio\" (SPR) ,", "root_cause_description": "Software change control", "action": "On July 17, 2025, Philips issued a \"Urgent Medical Device Correction\" Notification to affected consignees. Philips asked consignees to take the following actions: \n\n1. You may continue to use your system(s) in accordance with the intended use and by following the recommendations below.\n\n2. To prevent the issue from occurring, when using SPR generation, always verify data sets are from same acquisition and matching reconstruction parameters.\n\n3. Ensure that relevant clinical staff, including physicians, physicists, and dosimetrists, are informed about the potential for incorrect dataset calculations due to mixing of data sets 4D CT spectral and SPR generation.\n\n4. Circulate this notice to all users of this device so that they are aware of the potential issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed.\n\n5. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt of this letter via email to: Philips.recall@philips.com", "product_quantity": "149 Serial Numbers", "distribution_pattern": "Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.", "openfda": { "k_number": [ "K252863", "K081112", "K152488", "K223279", "K212274", "K071760", "K091492", "K040688", "K202789", "K112060", "K141860", "K260207", "K211379", "K150547", "K000922", "K232479", "K031349", "K252002", "K031281", "K041719", "K991815", "K082005", "K992303", "K051941", "K032209", "K171885", "K090531", "K100552", "K191384", "K172163", "K042861", "K193459", "K992753", "K250440", "K083414", "K211881", "K051497", "K002147", "K020027", "K020971", "K260308", "K151233", "K091145", "K193109", "K090808", "K243057", "K073020", "K141900", "K063230", "K002240", "K230557", "K153368", "K022411", "K240398", "K220582", "K983343", "K133247", "K982791", "K101220", "K093588", "K013673", "K220141", "K061440", "K211867", "K991237", "K093391", "K062967", "K152393", "K062514", "K252109", "K063482", "K170086", "K242378", "K021268", "K002312", "K091146", "K151435", "K123357", "K131891", "K201444", "K211511", "K253078", "K101119", "K241876", "K022741", "K993895", "K111311", "K201350", "K053584", "K220783", "K002509", "K092132", "K080888", "K250064", "K170969", "K203681", "K170355", "K142108", "K133331", "K080601", "K182888", "K173940", "K112446", "K992434", "K132816", "K101076", "K992762", "K081281", "K160093", "K031088", "K201607", "K032724", "K213787", "K260750", "K061097", "K083264", "K120363", "K131428", "K994413", "K181145", "K062032", "K180379", "K110730", "K130617", "K013644", "K223724", "K203469", "K242463", "K151469", "K071938", "K010682", "K252784", "K001700", "K121448", "K190664", "K002237", "K242748", "K180289", "K133655", "K052325", "K012575", "K214081", "K113102", "K993766", "K210645", "K213438", "K151380", "K171536", "K040474", "K222312", "K083672", "K192554", "K032456", "K123152", "K162370", "K223233", "K132971", "K193381", "K090972", "K141248", "K190387", "K253050", "K990071", "K993675", "K050296", "K011246", "K041971", "K032345", "K022961", "K202284", "K102915", "K102011", "K253091", "K161136", "K013661", "K120551", "K211841", "K022036", "K090893", "K170750", "K203766", "K200569", "K250963", "K151887", "K240671", "K990475", "K103515", "K013535", "K151369", "K984196", "K013112", "K143514", "K090182", "K103246", "K173635", "K151560", "K082642", "K234068", "K984532", "K982821", "K041997", "K211034", "K992864", "K042269", "K082606", "K102216", "K981678", "K222728", "K192065", "K092928", "K200608", "K080929", "K082221", "K083502", "K151666", "K061893", "K180308", "K140187", "K120387", "K002132", "K974770", "K232400", "K103093", "K112723", "K183037", "K071873", "K091179", "K241318", "K252304", "K100417", "K100056", "K242822", "K010784", "K030821", "K100092", "K193640", "K242992", "K141283", "K982696", "K041403", "K112776", "K022307", "K190178", "K222803", "K232799", "K915691", "K182665", "K200487", "K231825", "K123263", "K103146", "K042739", "K001295", "K143269", "K233236", "K012017", "K993923" ], "registration_number": [ "3022745617", "8043933", "3010123525", "3004555507", "3003418325", "3022719374", "3004526608", "3030564015", "3011716550", "3009302839", "3033527281", "3005136058", "2434141", "3016686005", "3003793371", "3013410552", "2939248", "9611894", "3003873069", "3007774465", "3004977335", "3023344262", "3025765259", "3004580128", "2030598", "3003768277", "3019543601", "1651102", "3003586672", "3007037519", "3008156050", "3004608878", "3007791541", "3009529630", "3015232217", "2183553", "3009077524", "3003094912", "3004363352", "3002808157", "3015777306", "3016602874", "3000126629", "2916710", "9617978", "3019834893", "3006894636", "3014425747", "1038814", "3044735888", "3014873236", "3042177665", "3012039133", "3018004899", "3004561814", "3009090417", "3010034862", "3006579682" ], "fei_number": [ "3022745617", "3010123525", "3004555507", "3003418325", "3022719374", "3004526608", "3030564015", "3011716550", "3009302839", "3033527281", "3005136058", "2434141", "3016686005", "3003793371", "3013410552", "2939248", "3003873069", "3007774465", "3004977335", "3023344262", "3025765259", "3004580128", "3019543601", "3003586672", "3007037519", "3008156050", "3004608878", "3007791541", "3002619595", "3009529630", "3015232217", "2183553", "3009077524", "3003094912", "3004363352", "1000518731", "3002808157", "3015777306", "3016602874", "3000126629", "2916710", "3006894636", "3019834893", "3008581796", "3014425747", "1038814", "3044735888", "3014873236", "3042177665", "3002802883", "3012039133", "3018004899", "3004561814", "3009090417", "3002807880", "3010034862", "3002807741", "3006579682" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }