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

Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Radiotherapy treatment for patients with malignant and benign diseases.

FDA Recall Z-2788-2011 · Posted 2011-07-11

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeMUJ
Date Initiated2011-05-20
Date Terminated2012-07-13
Product Quantity10,356

Reason for Recall

A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results.

Firm Action

Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail dated May 20, 2011, to all affected customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the product from use and advise users to manually initiate the configuration process for resampling to be applied when a previous calculation model is copied. Customers were asked to sign and return the notice to confirm receipt. For questions call USA and Canada 1-888-827-4265 For Europe call +41 41 749 8844

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102011ECLIPSE TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc. · 2010-09-03

Official Source

View FDA Recall →

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

↑