Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and d

FDA device recall Z-2041-2012 · posted 2012-07-19 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect

Action taken

The firm, VARIAN Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION; URGENT FIELD SAFETY NOTICE" dated June 18, 2012, to all affected users. The notice described the product, problem and actions to be taken. Varian is developing a technical correction for this issue. The customers will be contacted by a Varian Customer Service representative when this correction is available to schedule its installation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager. In USA and Canada: 1.888.VARIAN5 (888.827.4265) Europe: +41 41 749 8844; email: support-emea@varian.com Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; South East Asia: support-sea@varian.com; China/Asia: support-china@varian.com; Japan: support-japan@varian.com and Latin America: soporte.al@varian.com. Internet: Oncology systems customer site - www.myvarian.com and Varian Medical Systems public site - www.varian.com.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

MUJ

Quantity affected

7113 units

Distribution

Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hung

Date initiated

2012-06-18

Date posted

2012-07-19

Date terminated

2014-08-06

Location

Palo Alto, CA