{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104018", "product_res_number": "Z-0345-2012", "event_date_initiated": "2010-11-04", "event_date_posted": "2011-12-01", "recall_status": "Terminated", "event_date_terminated": "2012-03-02", "res_event_number": "59934", "product_code": "MUJ", "k_numbers": [ "K042861" ], "product_description": "Odyssey\n\nA radiation treatment planning system", "code_info": "Versions 4.4 through 4.7", "firm_fei_number": "3003166990", "recalling_firm": "PerMedics, Inc.", "address_1": "1425 Victoria Ct", "address_2": "Ste B", "city": "San Bernardino", "state": "CA", "postal_code": "92408-2808", "additional_info_contact": "909-478-5000 Ext. 234", "reason_for_recall": "Anomaly 1 - Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion, DICOM Image and RTP Link export files:\n\nDuring PerMedics' internal code reviews for lEC 61217 compliance verification, an issue was identified by PerMedics engineers in three export files: D1COM RT Ion Plan, D1COM RT Image and RTP Link. In some cases, this issue can result in table and/or collimator angle values t", "root_cause_description": "Device Design", "action": "PerMedics sent an Odyssey TPS URGENT NOTICE OF CORRECTION letter dated November 4, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:\nAnomaly 1 User Corrective Action:\n\nInstall the mandatory new version correcting the software as soon as it is available (see PerMedics Corrective Action below). In the meantime, the following recommendations were provided if they planned to use Odyssey RT Ion Plan, DICOM RT Image, and/or RTP Link export:\n\nWorkaround for the invalid exported table and/or collimator angle errors: \nIf, prior to the software correction, any of these affected file types were exported from Odyssey, manually verify that the table and collimator angles are correct. Additionally, apply appropriate changes to any angles deemed incorrect that were obtained from Odyssey's DICOM RT Ion Plan, DICOM RT Image, and/or RTP Link files.\n\nOnly those machines with table and/or collimator angles that increase in the clockwise direction will have the incorrect angles.\n\nAnomaly 2 User Corrective Action:\nInstall the mandatory new version correcting the software as soon as it is available (see PerMedics Corrective Action below). In the meantime, the following recommendations are provided if the user\n- Changes the patients scheduled start date prior to the software correction:\nWorkaround for Incorrect Monitor Unit Values when Changing Treatment Start Date: If, prior to the software correction, the user changes the patient's treatment start date on any fully-computed IMRT plan, IMAT plan or plan containing a \"Region DVH\" prescription, the user should force a full recommendation oft hose patient plans prior to fixing and exporting the plan.\nThe following procedure can be used to force a full re-computation of the plan:\n\n- Open the patient's plan worksheet\n- Change the algorithm type of the plan\n- Change the algorithm type back to its original value\n- Close t", "product_quantity": "15", "distribution_pattern": "Worldwide Distribution - USA including NY, GA, CA and the countries of Hungary, Brazil, China, India, Italy, and Mexico", "openfda": { "k_number": [ "K071873", "K180308", "K001295", "K161136", "K990475", "K031349", "K233236", "K013112", "K041997", "K112060", "K242992", "K993675", "K160093", "K181145", "K121448", "K130617", "K173940", "K172163", "K250963", "K090531", "K012017", "K203766", "K013535", "K062032", "K082221", "K152393", "K220582", "K080601", "K123152", "K002237", "K091179", "K201350", "K170355", "K090182", "K200487", "K123357", "K241318", "K252784", "K011246", "K992753", "K041719", "K021268", "K243057", "K093391", "K082606", "K132816", "K010784", "K201607", "K022741", "K083672", "K002147", "K212274", "K151369", "K032209", "K091492", "K061097", "K102011", "K190178", "K042269", "K041971", "K083502", "K211034", "K100552", "K223233", "K092928", "K062514", "K151233", "K151469", "K210645", "K022036", "K222728", "K223279", "K002509", "K090893", "K982821", "K990071", "K170086", "K211379", "K214081", "K192554", "K142108", "K071938", "K193109", "K112776", "K013661", "K983343", "K232479", "K041403", "K101076", "K100092", "K111311", "K080888", "K071760", "K123263", "K222312", "K230557", "K993895", "K051497", "K101220", "K223724", "K193640", "K252109", "K101119", "K171885", "K020027", "K992864", "K915691", "K080929", "K180379", "K982791", "K141283", "K182888", "K102216", "K020971", "K994413", "K131891", "K143514", "K151666", "K220141", "K182665", "K202284", "K211841", "K250064", "K082005", "K042861", "K132971", "K151380", "K211881", "K103246", "K040688", "K030821", "K240671", "K153368", "K002312", "K234068", "K260207", "K253091", "K211867", "K131428", "K242822", "K002240", "K252002", "K133655", "K993923", "K031281", "K083264", "K191384", "K091146", "K110730", "K143269", "K992434", "K231825", "K220783", "K982696", "K993766", "K252304", "K090808", "K063230", "K141860", "K112723", "K240398", "K050296", "K200569", "K253050", "K000922", "K241876", "K103146", "K133247", "K242748", "K040474", "K120363", "K053584", "K081112", "K193381", "K082642", "K171536", "K093588", "K051941", "K232799", "K250440", "K031088", "K013644", "K151887", "K252863", "K013673", "K032456", "K170750", "K203469", "K061893", "K061440", "K052325", "K100417", "K253078", "K232400", "K032724", "K152488", "K091145", "K151435", "K183037", "K112446", "K192065", "K022307", "K103093", "K083414", "K012575", "K974770", "K103515", "K073020", "K141248", "K981678", "K170969", "K002132", "K151560", "K201444", "K211511", "K063482", "K141900", "K190387", "K140187", "K260750", "K102915", "K180289", "K203681", "K150547", "K242378", "K992762", "K001700", "K991237", "K100056", "K133331", "K984532", "K092132", "K202789", "K173635", "K162370", "K242463", "K992303", "K190664", "K022411", "K984196", "K010682", "K120551", "K090972", "K120387", "K213438", "K032345", "K081281", "K113102", "K200608", "K222803", "K022961", "K991815", "K260308", "K062967", "K042739", "K193459", "K213787" ], "registration_number": [ "3010123525", "3004608878", "3011716550", "3030564015", "9617978", "3003094912", "3010034862", "3013410552", "3007791541", "3009077524", "3022745617", "3033527281", "1038814", "3003586672", "2183553", "3004977335", "3002808157", "3019834893", "3006579682", "3016602874", "3009302839", "3006894636", "3004580128", "2030598", "3014425747", "3016686005", "3007037519", "3004555507", "3025765259", "3025309924", "3003873069", "3004526608", "3019543601", "3003768277", "3042177665", "1651102", "9611894", "3018004899", "3044735888", "3003793371", "8043933", "3012039133", "3008156050", "3023344262", "3007774465", "2434141", "3015232217", "3015777306", "3009090417", "3022719374", "3000126629", "3003418325", "3004363352", "2939248", "3004561814", "3009529630", "3014873236", "3005136058", "2916710" ], "fei_number": [ "3010123525", "3004608878", "3011716550", "3030564015", "3003094912", "3010034862", "3013410552", "3007791541", "3009077524", "3022745617", "3033527281", "1038814", "3003586672", "2183553", "3004977335", "3002808157", "3019834893", "3006579682", "3016602874", "3009302839", "3006894636", "1000518731", "3014425747", "3004580128", "3016686005", "3007037519", "3004555507", "3025765259", "3025309924", "3003873069", "3004526608", "3019543601", "3042177665", "3002807880", "3002807741", "3018004899", "3044735888", "3003793371", "3012039133", "3008581796", "3008156050", "3023344262", "3002802883", "3007774465", "2434141", "3015232217", "3015777306", "3009090417", "3022719374", "3000126629", "3002619595", "3003418325", "3004363352", "2939248", "3004561814", "3009529630", "3014873236", "3005136058", "2916710" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }