Recall Z-2195-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radi
| Date | May 13, 2011 (initiated Mar 28, 2011) |
| Status | Terminated |
| Reason | Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail. |
| Root cause | Process control |
| Action | The firm, Varian Medical, sent an "Urgent Medical Device Correction" Letter dated March 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect all hard wedges for missing or sheared screw fasteners, if any wedge is found to have one or more missing or sheared screw fasteners, remove the wedge from use and notify Varian immediately; inspect all hard wedges for loose screw fasteners, and retighten as necessary, and implement a program of monthly inspection of wedges for loose or missing hardware. The cus |
| Quantity | 5616 units |
| 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 |