Recall Z-1045-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian High Energy Linear Accelerator: Varian Medical Systems, Palo Alto, CA 94304 Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
| Date | Feb 8, 2011 (initiated Dec 10, 2010) |
| Status | Terminated |
| Reason | An anomaly was identified whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification. |
| Root cause | Process control |
| Action | An Urgent Medical Device Correction letter was sent to all affected users with a description of the problem and user corrective action steps. Letters were sent on 12/10/2010. Users are to immediately investigate any unusual noises coming from the affected product and report them to whoever is responsible for servicing the device. For customers that do have a service contract with Varian, Varian service will perform an inspection of the counterweight bolts as part of the regular Periodic Maintenance Inspection procedure. Customers are to advice the appropriate personnel of the contents of t |
| Quantity | 1882 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100890 | VARIAN HIGH ENERGY LINEAR ACCELERATOR Varian Medical Systems, Jul 13, 2010 |