Z-2072-2010

TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI...

Name: Z-2072-2010 TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI...
Creator: TomoTherapy Incorporated
Published: 2010-06-23
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2010-06-23 / Terminated / root cause: software

FDA source

TomoTherapy Incorporated began a recall of TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System is intended to... on 2010-06-23. The reason FDA records is "An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect...". 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-2072-2010
Status: Terminated
Initiated: 2010-06-23
Posted: 2010-07-22
Terminated: 2011-12-17
Recalling firm: Accuray Incorporated
Product: TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation 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: An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect dose statistics.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were sent on 6/23/10 a TomoTherapy "Urgent Field Safety Notice Medical device Correction" letter dated June 22, 1010. The letter addressed the Issue, Product Affected, Recommended Action and Resolution. Prior to generating a draft or final Plan Report for a given plan, the plan must be closed and reopened at least once. This issue will be remedied by Hi-Art software version 4.0.3, scheduled for release in late 2010. Customers with questions were provided with a contact in the letter at the TomoTherapy Customer Interaction Center. The firm can be contacted at 608-824-2800.
Quantity in commerce: 29
Distribution: CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE.
Product codes and lots: Serial #'s: 110019, 110083, 110169, 110284, 110305, 110312, 110034, 110091, 110174, 110285, 110306, 110314, 110037, 110092, 110278, 110288, 110308, 110316, 110056, 110150, 110281, 110293, 110309, 110318, 110065, 110159, 110283, 110300, 110311

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)