Recall Z-0544-2008 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC, -- 6MV SRS photon beam, -- Fine Beam Isocenter Accuracy, -- Stereotactic motion disable. ----Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA
| Date | Feb 14, 2008 (initiated Sep 10, 2007) |
| Status | Terminated |
| Reason | Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle. |
| Root cause | Labeling design |
| Action | On 9/10/07, the firm issued an Urgent Medical Device Correction letter to all its direct consignees, informing them of the device defect and providing instructions on the recall. Short term user instructions were provided and the firm will schedule follow-up visits to make the needed permanent device corrections at each device site. |
| Quantity | 418 (total for Recalls Z-0544-0545-2008) |
| Distribution | Worldwide- Canada, Mexico, and the USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070094 | TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM Varian Medical Systems, Inc., Feb 9, 2007 |