Recall Z-0364-2012 ยท -IY
Varian Medical Systems, Inc. Oncology Systems
TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
| Date | Dec 2, 2011 (initiated Oct 31, 2011) |
| Status | Terminated |
| Reason | An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape. |
| Root cause | Device Design |
| Action | On 11/04/2011, an Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps. Varian is developing a corrective action for this issue. A customer service representative will contact you when the correction is available to schedule installation on your system. Questions regarding the letter should be directed to the Varian Oncology Help Desk Contact Information at USA and Canada: 1-888-827- 4265 or Europe +41-41-749-8844. |
| Distribution | Worldwide distribution including the US and Internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111106 | TRUEBEAM Varian Medical Systems, Inc., Aug 18, 2011 |