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.
Recall
- Recall Number
- Z-0464-2015
- Event Number
- 69515
- Firm
- Vision Rt Inc
- FEI Number
- 3017888782
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software in the Use Environment
- Initiated
- October 15, 2014
- Posted
- December 16, 2014
- Terminated
- May 10, 2016
- Address
- 8840 Stanford Blvd, Columbia, MD, 21045-5827
Description
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.
Potential failure of AlignRT to assert interlock.
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 [email protected]. Vision RT is designing an upgrade that will resolve the issue, and will subsequently contact the customer in order to install the upgrade on their device. Should you have any queries on this letter, please do not hesitate to contact Vision RT by telephone on +44 20 83464300 (866 778-2379 from the US) or as per http://www.visionrt.com/contact/details.
Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
7 (Six Units distribited in the US and One in OUS.)