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U.S. Department of Health and Human Services

Class 2 Device Recall HiArt System

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  Class 2 Device Recall HiArt System see related information
Date Initiated by Firm November 08, 2010
Date Posted December 27, 2010
Recall Status1 Terminated 3 on February 04, 2012
Recall Number Z-0814-2011
Recall Event ID 57337
510(K)Number K082005  
Product Classification Radiation Therapy Planning and Treatment System - Product Code MUJ
Product ThomoTherapy Hi-Art System

Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
Code Information Serial #'s  110019 110254 110299 110327 110024 110271 110300 110328 110051 110277 110303 110329 110056 110278 110308 110330 110091 110281 110309 110332 110092 110283 110310 110333 110174 110284 110311 110335 110202 110285 110313 110336 110243 110288 110318 110337 110251 110293 110326, and 110339.
Recalling Firm/
Manufacturer		 TomoTherapy Incorporated
1240 Deming Way
Madison WI 53717
For Additional Information Contact
608-824-2800
Manufacturer Reason
for Recall		 TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure.
FDA Determined
Cause 2		 Software design
Action Consignees were sent a TomoTherapy "Urgent Field Safety Notice" dated November 8, 2010. The letter addressed to TomoTherapy Customers described the Issue, Product Affected, Recommended Action and Resolution. Customers are to contact the TomoTherapy Customer Interaction Center for further instruction and assistance in generating a completion procedure, if they experience the issue. Questions should be directed towards the TomoTherapy Customer Interaction Center via email or telephone.
Quantity in Commerce 40 (21US; 19 OUS)
Distribution Worldwide Distribution -- USA, including the states of AZ, CO, IL, KS, MI, MO, NV, NY, ND, OH, OK PA, UT, and VA and countries of MALAYSIA, SWITZERLAND, KOREA, ITALY, SPAIN, CANDA, TAIWAN, JAPAN, BELGIUM
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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