Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2219-2010 · Posted 2010-08-12

Recalling FirmTomoTherapy Incorporated
Recall StatusTerminated
Product CodeMUJ
Date Initiated2009-12-01
Date Terminated2011-12-17
Product Quantity1

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

Firm 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.

Root Cause

Software design

Distribution Pattern

VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082005MODIFICATION TO HI-ART TREATMENT SYSTEMTomotherapy Incorporated · 2008-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑