TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. Intended to be used as an integrated system for 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-2115-2010 · Posted 2010-08-02
Advertisement
Recalling FirmTomoTherapy Incorporated
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-02-22
Date Terminated2011-02-10
Product Quantity7
Reason for Recall
In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.
Firm Action
Consignees were sent on 2/22/10 a TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated Monday, February 22, 2010. The letter was addressed to TomoTherapy Customer and identified the the affected product, and included a description of the Issue, Product Affected, Recommendation Actions and Resolution. The issue will be remedied by software versions 4.0.2 and later. Questions should be directed towards TomoTherapy Customer Interaction Center by e-mail or telephone.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.
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.
Advertisement