TomoTherapy Incorporated 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 accor Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 accor
Brand
TomoTherapy Incorporated
Lot Codes / Batch Numbers
110019
Products Sold
110019
TomoTherapy Incorporated is recalling Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integ due to 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 r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
VA
Page updated: Jan 10, 2026