Z-0814-2011

ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning and precise delivery...

Name: Z-0814-2011 ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning and precise delivery...
Creator: TomoTherapy Incorporated
Published: 2010-11-08
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2010-11-08 / Terminated / root cause: software

FDA source

TomoTherapy Incorporated began a recall of ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy... on 2010-11-08. The reason FDA records is "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". 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-0814-2011
Status: Terminated
Initiated: 2010-11-08
Posted: 2010-12-27
Terminated: 2012-02-04
Recalling firm: Accuray Incorporated
Product: 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 40 (21US; 19 OUS)
Distribution: 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
Product codes and lots: Serial #'s 110019 110254 110299 110327 110024 110271 110300 110328 110051 110277 110303 110329 110056 110278 110308 110330 110091 110281 110309 110332 110092 110283 110310 110333 110174 110284 110311 110335 110202 110285 110313 110336 110243 110288 110318 110337 110251 110293 110326, and 110339.

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)