{ "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": "91633", "product_res_number": "Z-0159-2011", "event_date_initiated": "2010-02-19", "event_date_posted": "2010-10-28", "recall_status": "Terminated", "event_date_terminated": "2011-03-28", "res_event_number": "55712", "product_code": "MUJ", "k_numbers": [ "K981313" ], "product_description": "Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. \nThe intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine.", "code_info": "Sequencer for MOSAIQ 1.60W3 (including all service packs), 2.00T2 (inclusing all service packs), 2.10L5 (including all service packs) and 2.10M7 (including all service packs).", "firm_fei_number": "1000123805", "recalling_firm": "Impac Medical Systems Inc", "address_1": "100 Mathilda Pl Fl 5th", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-6076", "additional_info_contact": "408-830-8007", "reason_for_recall": "Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.", "root_cause_description": "Process change control", "action": "ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers.\nCustomers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery.\nReview all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately. \nA workaround was to be re-imported into their current version of MOSAIQ.\nIMPAC Support was to follow-up with each site and execute a script to detect and correct all affected treatment plans.\nFor questions, concerns, and requests for upgrade, customers were to email support@impac.com or call their support center.", "product_quantity": "19 units.", "distribution_pattern": "Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy", "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", 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