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

Linear accelerator workstation software suite

FDA Recall Z-1084-04 · Posted 2004-07-20

Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2004-05-27
Date Terminated2004-12-20
Product Quantity155 units

Reason for Recall

An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1

Firm Action

Varian will notify customers via phone beginning 5/27/2004 and distribute a product notification letters June 3, 2004, notifying them of the anomaly and corrective action, and finally, the anomaly will be corrected by a future release of software.

Root Cause

Software design

Distribution Pattern

units were distributed throughout the US and Canada, as well as approximately 66 other foreign consignees, including

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990085MILLENNIUM MLC -120Varian Assoc., Inc. · 1999-02-08

Official Source

View FDA Recall →

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

↑