Z-2219-2010

Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated...

Name: Z-2219-2010 Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated...
Creator: TomoTherapy Incorporated
Published: 2009-12-01
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2009-12-01 / Terminated / root cause: software

FDA source

TomoTherapy Incorporated began a recall of Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of... on 2009-12-01. The reason FDA records is "An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and...". 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-2219-2010
Status: Terminated
Initiated: 2009-12-01
Posted: 2010-08-12
Terminated: 2011-12-17
Recalling firm: Accuray Incorporated
Product: Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is 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. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs allow for images to be moved during planning. During registration when roll is applied on moved images, the Operator Station incorrectly rolls the image about
Root cause tag: software
FDA root cause: Software design
Action: Consignee was sent a TomoTherapy "Urgent Medical device Correction Field Safety Notice' dated December 01, 2009. The letter described the Issue, Product Affected, Recommended Action and Resolution.
Quantity in commerce: 1
Distribution: VA
Product codes and lots: 110019

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)