VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by Varian Medical Systems, Palo Alto
FDA device recall Z-0133-2010 · posted 2009-11-09 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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, Ma
- Date initiated
- 2009-09-15
- Date posted
- 2009-11-09
- Date terminated
- 2011-07-29
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIS 1.4G (K001643) | Varian Medical Systems, Inc. | 2000-06-23 |