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Terminated

VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by Varian Medical Systems, Palo Alto, CA.

FDA Recall Z-0133-2010 · Posted 2009-11-09

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-09-15
Date Terminated2011-07-29
Product Quantity100 units

Reason for Recall

Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed.

Firm Action

Recall initiated September 15, 2009. An "Urgent - Field Safety Notice" letter was distributed to all affected users, with a description of the problem and corrective action steps. The letter was also distributed to Varian sales, marketing, and service organizations, informing them of the issue. For further information in the USA and Canada, contact Varian at 1-650-424-5731 or 1-888-VARIAN5 (888- 827-4265). In Europe, contact +41 41 749 8844.

Root Cause

Software design

Distribution Pattern

Worldwide distribution to 100 consignees throughout the US in IL, NY, MI, NJ, AL, TN, MD, OH, FL, and TX, and to Brazil, Chile, China, Czech Republic, Egypt, Germany, Hungary, Israel, Italy, Japan, Malaysia, the Netherlands, Romania, Slovakia, Slovenia, South Korea, Spain, Taiwan, Thailand and the United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001643VARIS 1.4GVarian Medical Systems, Inc. · 2000-06-23

Official Source

View FDA Recall →

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

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