{ "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": "65676", "product_res_number": "Z-0169-2008", "event_date_initiated": "2007-03-22", "event_date_posted": "2007-11-09", "recall_status": "Terminated", "event_date_terminated": "2010-12-18", "res_event_number": "38516", "product_code": "IYE", "k_numbers": [ "K993425" ], "product_description": "PRIMUS Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 4504200,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520", "code_info": "MODEL NUMBER: 4504200; Serial Numbers: 2701, 2733, 2762, 2768, 2823, 2827, 2828, 2836, 2839, 2842, 2846, 2848, 2863, 2867, 2887, 2893, 2894, 2896, 2899, 2911, 2912, 2914, 2931, 2933, 2934, 2936, 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The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during \"Service Mode.\"", "root_cause_description": "Software design", "action": "Distribution of Update Instructions TH007/07/S was sent to all affected sites on March 26, 2007. This was intended to inform users that Service Mode is only for use by authorized personnel, and that unauthorized and/or incorrect softpot parameter changes performed in Service Mode can result in the risk of patient mistreatment.\nCurrent control system software versions do not allow unplanned Dosimetry calibration data sets to be erroneously copied during \"Service Mode.\"", "product_quantity": "687 units", "distribution_pattern": "Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and \nFOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. 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