Recall Z-0106-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
| Date | Oct 20, 2010 (initiated May 24, 2010) |
| Status | Terminated |
| Reason | Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects "Apply Shift" and presses Motion Enable buttons. This can result in the actual patient position differing from that position indicated by the imaging application affecting poistion accuracy and precision. |
| Root cause | Software design |
| Action | Varian Medical Systems issued an Urgent Medical Device Correction letter date dated May 24, 2010 to users identifying the affected device, the issue prompting the correction, and the actions to be taken by the user. Customers were asked to set couch tolerance values to small numbers, and for radiosurgical treatment tolerance values to be set to zero. A Varian representative will contact customers to schedule installation of a software version correcting the issue. US Customers can contact Varian at 1-888-827-4265,. European customers can contact Varian at +41 41 749 8844. |
| Distribution | Worldwide Distribution: Two consignees, one in the US and one in Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092871 | TRILOGY MX Varian Medical Systems, Inc., Nov 30, 2009 |