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U.S. Department of Health and Human Services

Class 2 Device Recall AlignRT

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  Class 2 Device Recall AlignRT see related information
Date Initiated by Firm October 15, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on May 10, 2016
Recall Number Z-0464-2015
Recall Event ID 69515
510(K)Number K123371  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 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.
Code Information Affected software version:  Software versions 5.0.1738 and 5.0.1742 only.  Affected serial numbers:  248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139.   
Recalling Firm/
Manufacturer		 Vision Rt Inc
8840 Stanford Blvd
Columbia MD 21045-5827
For Additional Information Contact Anthony Palin
866-594-5443
Manufacturer Reason
for Recall		 Potential failure of AlignRT to assert interlock.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VISION RT LIMITED
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