Z-2115-2010

TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI...

Name: Z-2115-2010 TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI...
Creator: TomoTherapy Incorporated
Published: 2010-02-22
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2010-02-22 / Terminated / root cause: software

FDA source

TomoTherapy Incorporated began a recall of 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... on 2010-02-22. The reason FDA records is "In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2115-2010
Status: Terminated
Initiated: 2010-02-22
Posted: 2010-08-02
Terminated: 2011-02-10
Recalling firm: Accuray Incorporated
Product: 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 7
Distribution: Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.
Product codes and lots: Serial #'s: 110019. 110037, 110056, 110091, 110169, 110281.

Product code MUJ

K082005Class IIModification to Hi-Art Treatment SystemTomotherapy Incorporated / cleared 2008-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)