Recall Z-1617-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. Varian Medical Systems, Palo Alto, CA.
| Date | May 16, 2012 (initiated Apr 9, 2012) |
| Status | Terminated |
| Reason | Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the operator should be aware of. |
| Root cause | Labeling design |
| Action | An "Urgent Medical Device Correction / Field Safety Letter" was distributed to all affected users on April 9, 2012, with a description of the problem and user corrective action steps. The Letter was also distributed to the Varian Sales, Marketing, and Service organizations. Customers in the US and Canada may contact (888) 827-4265 for questions. *** An additional letter was sent on 11/5/12 to additional consignees identified by Varian as being affected the the recall but not previously notified. |
| Quantity | 207 devices 12/7/12 - amended to 216 devices. |
| Distribution | Worldwide Distribution -- USA, and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Netherlands, New Zealand, Norway, Portugal, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111106 | TRUEBEAM Varian Medical Systems, Inc., Aug 18, 2011 |