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U.S. Department of Health and Human Services

Class 2 Device Recall TomoTherapy HiArt System, ver. 4.0.0, 4.0.1, 4.0.2.

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  Class 2 Device Recall TomoTherapy HiArt System, ver. 4.0.0, 4.0.1, 4.0.2. see related information
Date Initiated by Firm June 23, 2010
Date Posted July 22, 2010
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-2072-2010
Recall Event ID 56056
510(K)Number K082005  
Product Classification Radiation Therapy System - Product Code MUJ
Product TomoTherapy Hi-Art System¿, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System¿ 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 healthy tissue.
Code Information Serial #'s:  110019, 110083, 110169, 110284, 110305, 110312, 110034, 110091, 110174, 110285, 110306, 110314, 110037, 110092, 110278, 110288, 110308, 110316, 110056, 110150, 110281, 110293, 110309, 110318, 110065, 110159, 110283, 110300, 110311
Recalling Firm/
Manufacturer		 TomoTherapy Incorporated
1240 Deming Way
Madison WI 53717
For Additional Information Contact
608-824-2800
Manufacturer Reason
for Recall		 An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect dose statistics.
FDA Determined
Cause 2		 Software design
Action Consignees were sent on 6/23/10 a TomoTherapy "Urgent Field Safety Notice Medical device Correction" letter dated June 22, 1010. The letter addressed the Issue, Product Affected, Recommended Action and Resolution. Prior to generating a draft or final Plan Report for a given plan, the plan must be closed and reopened at least once. This issue will be remedied by Hi-Art software version 4.0.3, scheduled for release in late 2010. Customers with questions were provided with a contact in the letter at the TomoTherapy Customer Interaction Center. The firm can be contacted at 608-824-2800.
Quantity in Commerce 29
Distribution CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE.
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 = MUJ and Original Applicant = TOMOTHERAPY INCORPORATED
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