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

Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments.

FDA Recall Z-2308-2008 · Posted 2008-09-17

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-06-11
Date Terminated2011-03-10
Product Quantity907 units

Reason for Recall

Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters.

Firm Action

Recall initiated June 11, 2008 when the firm issued an Urgent Device Correction recall letter. The letter was distributed to all affected users, with problem description and user corrective action steps. If you have questions, contact your local Varian Customer Support Representative.

Root Cause

Software design

Distribution Pattern

Product was distributed throughout the USA and to Argentina, Australia, Austria, Belgium, Byelorussia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, India, Israel, Iran, Italy, Ireland, Japan, Kozak, Latvia, Lebanon, Libya, Macau, Macedonia, Malaysia, Mexico, Morocco, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Russian Fed., Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, R.O.C., Thailand, The Netherlands, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010975ECLIPSE 6.5Varian Medical Systems, Inc. · 2001-05-02

Official Source

View FDA Recall →

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

↑