Recall Z-2181-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
| Date | May 10, 2011 (initiated Apr 5, 2011) |
| Status | Terminated |
| Reason | Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain video intensities are not available on one of the two cameras. The image has abnormally abrupt transitions from dark to light portions, without the normal shades of gray. |
| Root cause | Nonconforming Material/Component |
| Action | Varian Urgent Medical Device Correction, Urgent Field Safety Notice letters were sent to all affected facilities by certified mail on April 5, 2011. |
| Quantity | 20 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092871 | TRILOGY MX Varian Medical Systems, Inc., Nov 30, 2009 |