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.
This recall has been terminated (originally issued August 2, 2010).
- Company
- Tomotherapy Incorporated
- Recall Initiated
- February 22, 2010
- Posted
- August 2, 2010
- Terminated
- February 10, 2011
- Recall Number
- Z-2115-2010
- Quantity
- 7
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
Reason for Recall
In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.
Distribution
Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.
Lot / Code Info
Serial #'s: 110019. 110037, 110056, 110091, 110169, 110281.
Root Cause
Software design
Action Taken
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.