Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Product Usage: Eclipse Treatment Planning Syste

FDA device recall Z-3002-2011 · posted 2011-08-11 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

In affected Eclipse versions, the treatment field energy may change from the current selection to a previous selection without use intervention and without invalidating the MU or calculated dose distribution.

Action taken

Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 30, 2011 to all affected consignees. The letter identifies the affected product, problem, and actions to be taken. The letter states that Varian will contact all affected customers to apply a database configuration script to the database and is preparing a correction for Eclipse Version 10 to address the issue. A Varian representative will contact each site to schedule correction when it is available. The letter also provides RECOMMENDED USER ACTIONS to follow. The Letters go on to reiterate caution and warnings from Eclipse instructions for use. All appropriate personnel should be notified of the correction notice. For future reference, this document will be posted to the Varian customer support website: http://www.MyVarian.com. For further clarification, contact your local Varian Customer Support District or Regional Manager.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

2436

Distribution

Worldwide Distribution.

Date initiated

2011-06-30

Date posted

2011-08-11

Date terminated

2014-05-09

Location

Palo Alto, CA

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