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Terminated

Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48

FDA Recall Z-1612-2008 · Posted 2008-09-23

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeMUJ
Date Initiated2008-02-13
Date Terminated2011-05-17
Product Quantity90 units

Reason for Recall

A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.

Root Cause

Software design

Distribution Pattern

Product was distributed throughout the USA (in LA, IN, GA, MD, IL, AR, CA, MA, FL, AZ, SC, MO, CO, AL, OK, WA, MI, IN, NY, TX, MS, NE, TN, VA, WI, OR, DC, and NC) and internationally (Japan, Columbia, Canada, India, Czech Republic, Turkey, Germany, Portugal, Venezuela, Australia, South Korea).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071873MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc. · 2007-08-09

Official Source

View FDA Recall →

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

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