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.
This recall has been terminated (originally issued November 9, 2009).
- Recall Initiated
- September 15, 2009
- Posted
- November 9, 2009
- Terminated
- July 29, 2011
- Recall Number
- Z-0133-2010
- Quantity
- 100 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
Codes H850008, H850904, H851353, H851333, H880033, H850907, H851388, H881354, H850078, H850912, H851674, H881389, H850110, H850920, H851838, H881392, H850129, H850930, H851992, H881393, H850130, H850962, H852053, H881410, H850211, H850963, H852544, H881482, H850217, H850964, H852546, H881483, H850258, H850965, H880004, H881484, H850322, H850967, H880012, H881515, H850345, H850968, H880098, H881524, H850350, H850969, H880221, H881557, H850451, H851020, H880449, H881576, H850474, H851025, H880699, H881586, H850555, H851032, H880720, H881641, H850616, H851059, H880734, H881642, H850686, H851080, H880809, H881658, H850696, H851087, H880862, H881671, H850739, H851091, H881033, H881839, H850759, H851132, H881037, H881865, H850788, H851138, H881060, H881895, H850830, H851145, H881102, H881951, H850831, H851252, H881205, H881993, H850861, H851290, H881207, H882003, H850877, H851327, H881220, H882049, H882623, H885074
Root Cause
Software design
Action Taken
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.