Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands Indicated for sterostatic r
FDA device recall Z-2778-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Some drive stand bolts may fail to meet mechanical specifications.
- Action taken
- Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers. The letter included a description of product, problem and recommendations. This includes performing daily QA to detect isocenter shift and the use of independent patient position system. Customers are advised to discontinue its use if a shift is detected and to contact Varian Medical Systems for a replacement stand bolts and adjustment if necessary. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 36
- Distribution
- Worldwide distribution: (USA) Nationwide including the states of PA. NJ, NY, MA, VA, TX, KS, FL, OH, SC, MN, CA, TN and NV; and the countries of Canada, Colombia, France, Italy, Japan, Netherlands and
- Date initiated
- 2011-05-13
- Date posted
- 2011-07-11
- Date terminated
- 2012-07-13
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890) | Varian Medical Systems | 2010-07-13 |
| TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K033343) | Varian Medical Systems, Inc. | 2003-12-23 |