Recall Z-0934-2015 ยท IYE Accelerator, Linear, Medical
Vision Rt Inc
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
| Date | Jan 7, 2015 (initiated Nov 11, 2014) |
| Status | Terminated |
| Reason | Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened. |
| Root cause | Under Investigation by firm |
| Action | VisionRT sent an Urgent Medical Device Correction Notification letter dated November 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers shall: A. Print the instructions in Appendix 3, place them in the front of the product guide and ensure these instructions are read and understood by all those who need to be aware of them within their organisation; B. Maintain awareness of this issue until all actions indicated in this letter have been successfully completed; C. Promptly inform Vision RT if they believe |
| Quantity | 55 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052682 | ALIGNRT Vision RT Limited, Jan 6, 2006 |