FDA Medical Device Recalls (openFDA)
Varian Medical Systems Oncology Systems: 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.
- Recall number
- Z-0133-2010
- Recalling firm
- Varian Medical Systems Oncology Systems
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-09-15
- Posted
- 2009-11-09
- Terminated
- 2011-07-29
- Reason
- 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.
- Root cause
- Software design
- 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.
- Quantity
- 100 units
- 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, serial or model codes
- 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
- 510(k) numbers
- ["K001643"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28