Recall Z-0133-2010 ยท IYE Accelerator, Linear, Medical
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.
| Date | Nov 9, 2009 (initiated Sep 15, 2009) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001643 | VARIS 1.4G Varian Medical Systems, Inc., Jun 23, 2000 |