Recall Z-2778-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
| Date | Jul 11, 2011 (initiated May 13, 2011) |
| Status | Terminated |
| Reason | Some drive stand bolts may fail to meet mechanical specifications. |
| Root cause | Nonconforming Material/Component |
| Action | 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- 8 |
| Quantity | 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 United Kingdom. |
| FDA record | Open on fda.gov |