Recall Z-0464-2015 ยท IYE Accelerator, Linear, Medical
Vision Rt Inc
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
| Date | Dec 16, 2014 (initiated Oct 15, 2014) |
| Status | Terminated |
| Reason | Potential failure of AlignRT to assert interlock. |
| Root cause | Software in the Use Environment |
| Action | The firm, visionrt. sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION-URGENT FIELD SAFETY NOTICE" dated October 15, 2014 to all affected customers on 21-Oct-2014. The notice describes the product, problem and actions to be taken. The customers were informed that they did not need to return their devices; they should pass the letter to all those who need to be aware of it within their organization; promptly inform Vision RT if they believe that patient harm occurred due this issue, and complete and return the acknowledgement form via email to service@visionrt.com. Vision RT is designing a |
| Quantity | 7 (Six Units distribited in the US and One in OUS.) |
| Distribution | Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123371 | ALIGNRT PLUS Vision RT Limited, Jan 8, 2013 |