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.
FDA Recall Z-0814-2011 · Posted 2010-12-27
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Recalling FirmTomoTherapy Incorporated
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-11-08
Date Terminated2012-02-04
Product Quantity40 (21US; 19 OUS)
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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