Recall Z-2046-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System; Model #s: H14, H18, H27, 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 radiot
| Date | Feb 24, 2011 |
| Status | Terminated |
| Reason | The wedge angle labeling on the wedge tray may not correctly match the wedge body. However, the wedge body is labeled with the correct wedge angle. |
| Root cause | Labeling mix-ups |
| Action | The firm, Varian Medical, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 24, 2011, to all affected users. The letter described the product, problem and actions to be taken. The customers were instructed to IMMEDIATELY inspect all wedges to verify that the wedge angle label on the wedge body matches the wedge angle on the wedge tray; if any wedge is identified with mismatched labeling follow the written instructions provided in the letter; always measure wedge data at installation of new or replacement wedges; verify all treatment accessories of "matched" linear accelerator |
| Quantity | 5541 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 |