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Terminated

Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..

FDA Recall Z-2702-2011 · Posted 2011-06-29

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeMUJ
Date Initiated2011-05-03
Date Terminated2014-07-09
Product Quantity5201 units ***12-12-12 AMENDED TO: 5448 units***

Reason for Recall

In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose to be higher than planned locally by up to 10%.

Firm Action

Varian Medical Systems, Inc. Oncology Systems sent a "Urgent Medical Device Correction" letters on May 3, 2011 ***12-12-12, 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 contained recommended actions. For additional information contact Varian Medical Systems, Inc. at 888- 827-4265.

Root Cause

Software design

Distribution Pattern

Worldwide distribution; Nationwide (USA) and the countries of Vietnam, Venezuela, United Kingdom, United Arab Emirates, Ukraine, Turkey, Tunisia, Trinidad and Tobago, Thailand, Taiwan, Syria, Switzerland, Sweden, Sri Lanka, Spain, South Korea, South Africa, Slovenia, Singapore, Saudi Arabia, Russia, Romania, Qatar, Portugal. Poland, Philippines, Panama, Pakistan, Norway, New Zealand, Netherlands, Morocco, Mexico, Malaysia, Macau, Lithuania, Libya, Latvia, Kuwait, Kazakjstan, Japan, Italy, Israel, Ireland, Iraq, Indonesia, India, Hungary, Hong Kong,, Guam, Greece, Germany, France, Finland, Egypt, Ecuador, Denmark, Czech Republic, Colombia, China, Canada, Brazil, Belgium, Belarus, Bangladesh, Bahrain, Austria, Australia, Argentenia, Algeria and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073020ECLIPSE TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc. · 2007-12-19

Official Source

View FDA Recall →

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

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