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U.S. Department of Health and Human Services

Class 2 Device Recall Radiation Therapy System

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  Class 2 Device Recall Radiation Therapy System see related information
Date Initiated by Firm October 14, 2008
Date Posting Updated January 22, 2009
Recall Status1 Terminated 3 on February 10, 2011
Recall Number Z-0628-2009
Recall Event ID 50147
510(K)Number K060912  
Product Classification Accelerator, linear, medical - Product Code IYE
Product TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal.

TomoTherapy HI-ART Systems is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital health tissue. The HI-Art system's planning station or operator station is intended to be used by the physician/oncologists to prescribe a radiation therapy plan for a particular patient,. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage (MVCT) scan (a CT using the on board linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The TomoImage (MVCT) image is not for diagnostic use. When patient positioning is complete, the HI-ART System i sthen intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.
Code Information Domestic Customer Information, Serial number:, 110001, 110002, 110003, 110004, 110005, 110006, 110007, 110008, 110012, 110013, 110015, 110016, 110017, 110019, 110020, 110021, 110022, 110023, 110024, 110025, 110026, 110027, 110028, 110029, 110030, 110031, 110032, 110033, 110035, 110038, 110039, 110040, 110041, 110042, 110043, 110044, 110045, 110047, 110048, 110050, 110051, 110053, 110054, 110056, 110057, 110059, 110060, 110066, 110067, 110073, 110074, 110080, 110081, 110082, 110084, 110086, 110087, 110089, 110090, 110091, 110092, 110094, 110095, 110096, 110097, 110098, 110100, 110103, 110104, 110105, 110106, 110108, 110112, 110115, 110116, 110118, 110119, 110120, 110122, 110127, 110132, 110134, 110135, 110138, 110139, 110141, 110144, 110145, 110148, 110149, 110152, 110153, 110154, 110155, 110158, 110160, 110161, 110165, 110166, 110168, 110173, 110174, 110175, 110176, 110177, 110179, 110180, 110181, 110185, 110186, 110187, 110188, 110190, 110192, 110193, 110195, 110196, 110197, 110198, 110201, 110202, 110203, 110204, 110206, 110209, 110210, 110213, 110214, 110215, 110216, 110217, 110221, 110222, 110223, 110225, 110227, 110238, 110242, 110224 and, 110250., International Customer Information, Serial number:, 110009, 110014, 110018, 110034, 110036, 110037, 110046, 110049, 110052, 110055, 110058, 110061, 110062, 110063, 110064, 110065, 110068, 110069, 110071, 110072, 110075, 110076, 110077, 110078, 110079, 110083, 110085, 110088, 110093, 110107, 110109, 110110, 110111, 110113, 110114, 110117, 110123, 110124, 110126, 110128, 110129, 110130, 110131, 110133, 110136, 110137, 110140, 110142, 110143, 110146, 110150, 110151, 110156, 110157, 110159, 110162, 110164, 110167, 110169, 110170, 110171, 110172, 110178, 110182, 110183, 110189, 110191, 110194, 110199, 110200, 110207, 110211, 110228, 110237 and, 110240..
Recalling Firm/
Manufacturer
TomoTherapy Incorporated
1240 Deming Way
Madison WI 53717
For Additional Information Contact
608-824-2800
Manufacturer Reason
for Recall
TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the "Superuser" and "Field Service engine
FDA Determined
Cause 2
Software design
Action A TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated October 17, 2008 was sent to all consignees. The letter addressed the Issue, Product Affected, Recommended Actions and Resolution. Please direct questions to the TomoTherapy, Inc. Customer Care Center by email (www.support@tomotherapy.com) or by telephone, North America: 1-866-368- 4807 and all other locations: 1-608-824-2900 or 32-2-400-44-44.
Quantity in Commerce 215
Distribution Worldwide Distribution --- USA including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NM, NY, OH,OK , OR, PR, PA, SC, SD, TN, TX, VA, WA, WI, WY, and DC, and countries of BELGIUM, CANADA, SWITZERLAND, CHINA, GERMANY, SPAIN, FRANCE, GREAT BRITAIN, HONG KONG, ITALY, JAPAN, KOREA, NETHERLANDS, SINGAPORE, TAIWAN and TURKEY.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = TOMOTHERAPY INCORPORATED
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