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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 July 07, 2011
Create Date June 26, 2015
Recall Status1 Terminated 3 on June 29, 2012
Recall Number Z-3163-2011
Recall Event ID 59427
510(K)Number K082005  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717

The TomoTherapy HI-ART System is 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. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
Code Information Serial Numbers: 110051 110101 110298 110329
Recalling Firm/
Manufacturer		 Accuray Incorporated
1240 Deming Way
Madison WI 53717-1954
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 TomoMobile Hi-Art System. TomoTherapy has discovered that when attempting to open the TomoMobile shielding doors, while the door hinges are in the locked position, the hinges may fail allowing the door to disengage from the shielding.
FDA Determined
Cause 2		 Device Design
Action The firm, TomoTherapy, sent an "Urgent Medical Device Correction" letter dated July 7, 2011 to its consignees/customers. The letter described the Issue, Product Affected, Recommended Action (advised consignees to not attempt to open the shielding doors when the hinges are in the locked position. The Hinges should always be in the unlocked position when opening the doors) and Resolution. A TomoTherapy field service engineer or an authorized service representative will contact the customers when a resolution is available. If you have any questions, please contact the TomoTherapy Technical Solutions Center by email at support@tomotherapy.com or phone at: North America: 1-866-368-4807; Belgium: 0800 38783; France: 0805 631 565; Germany: 0800 000 7541; Italy: 800 986 399; Netherlands: 0800 020 1364; Spain: 800 300049; Switzerland: 0800 001927; United Kingdom: 0808 238 6035; China/CNC (Northern): 10 800 712 1701; China (Southern): 10 800 120 1701; Hong Kong: 800 967912; Japan: 0044 22 132374; Singapore: 800 1204 683; South Korea: 0079 81 4800 7204, all other locations: +1 608 824 2900 or +32 2 400 44 44.
Quantity in Commerce 4
Distribution Worldwide distribution: USA including states of: AZ, CA and OK; and country of: United Arab Emirates
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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