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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Varian Medical Systems Oncology Systems
Lot Codes / Batch Numbers
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
Products Sold
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
Varian Medical Systems Oncology Systems is recalling VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by Varian Medic due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, FL, IL, IN, MD, MI, NJ, NY, OH, TN, TX
Page updated: Jan 10, 2026