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.
FDA Recall Z-0464-2015 · Posted 2014-12-16
Recalling FirmVision Rt Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-10-15
Date Terminated2016-05-10
Product Quantity7 (Six Units distribited in the US and One in OUS.)
Reason for Recall
Potential failure of AlignRT to assert interlock.
Firm 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 [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.
Root Cause
Software in the Use Environment
Distribution Pattern
Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.