{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "105776", "product_res_number": "Z-0594-2012", "event_date_initiated": "2011-11-18", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2014-02-28", "res_event_number": "60549", "product_code": "IYE", "k_numbers": [ "K041577" ], "product_description": "Pinnacle3 Radiation Therapy Planning System, software version 9.0.\n\nModel #\t Description\n453560446041\tPinnacle3 version 9.0 English\n453560446051\tPinnacle3 version 9.0 Simplified Chinese\n453560446061\tPinnacle3 version 9.0 Traditional Chinese\n453560446091 \tPinnacle3 version 9.0 Dutch\n453560446101\tPinnacle3 version 9.0 French\n453560446111\tPinnacle3 version 9.0 German\n453560446141\tPinnacle3 version 9.0 Italian\n453560446161\tPinnacle3 version 9.0 Japanese\n453560446181\tPinnacle3 version 9.0 Spanish\n453560446201\tPinnacle3 version 9.0 Turkish\n\nIntended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.", "code_info": "System Code # 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446111 453560446111 453560446041 453560446101 453560446041 453560446101 453560446041 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446051 453560446041 453560446041 453560446041 453560446101 453560446101 453560446041 453560446101 453560446041 453560446111 453560446041 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446111 453560446051 453560446041 453560446141 453560446141 453560446041 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446041 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446161 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446041 453560446181 453560446181 453560446101 453560446041 453560446061 453560446041 453560446061 453560446061 453560446041 453560446041 453560446041 453560446201 453560446041 453560446041 453560446041 453560446041 453560446041", "firm_fei_number": "3004022368", "recalling_firm": "Philips Medical Systems (Cleveland), Inc.", "address_1": "5520 Nobel Dr Ste 125 5520 Nobel Dr", "address_2": "Ste 125", "city": "Fitchburg", "state": "WI", "postal_code": "53711-4948", "additional_info_contact": "608-298-6901", "reason_for_recall": "Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry.", "root_cause_description": "Software design", "action": "Consignees were sent on 11/18/11 a Philips \"Urgent Medical Device Correction\" letter dated 2011 Nov 16. The letter identified the affected product and described the Problem, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer/User, Actions Planned by Philips and Further information and Support. If customers observed the issue, they were to manually make the suggested change. In addition, customers were to place the letter in the Instructions for Use until otherwise notified. The firm will deliver 9.2 software release free of charge. Customers in North America are to contact Customer Care Solutions Center at 1-800-722-9377, if they have questions or need support concerning the recall.", "product_quantity": "715 (463 US)", "distribution_pattern": "Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and countries of AUSTRALIA, AUSTRIA, BELGIUM, CHINA, DENMARK, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, OMAN, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM, and CANADA.", "openfda": { "k_number": [ "K972804", "K102671", "K930182", "K962080", "K152321", "K130678", "K052920", "K202747", "K020320", "K926008", "K943464", "K090044", "K932598", "K913612", "K223229", "K924495", "K051932", "K960510", "K210894", "K031634", "K223839", 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"device_name": "Accelerator, Linear, Medical", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }