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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 November 11, 2014
Date Posted January 07, 2015
Recall Status1 Terminated 3 on May 11, 2016
Recall Number Z-0934-2015
Recall Event ID 70009
510(K)Number K052682  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 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.
Code Information Serial numbers (internally referred to as PCR numbers):   USA: 247-018, 247-039, 247-040, 247-053, 247-060, 247-061 , 247-062, 247-063, 247-068, 247-071 , 247-075, 247-076 , 247-078, 247-081, 247-083, 247-096, 247-099, 247-100,, 247-101, 247-102 , 247-110 , 247-118, 247-119, 247-122, 247-124, 247-127, 247-129, 247-130, 247-138, 247-140, 247-142, 247-149, 247-150, 247-153, 247-161, 247-167, 247-171, 247-184, 247-194, 247-200, 247-207, 247-212, 247-213, 248-012, 248-018, 248-041  Rest of the world:  247-035, 247-073, 247-114, 247-131, 247-147, 247-148, 247-188 
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 use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
FDA Determined
Cause 2		 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 that patient harm occurred due to this issue; AND D. Complete the acknowledgement in Appendix 1 and return it via email to corrections@visionrt.com. Contact Vision RT 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. For questions regarding this recall call 866-594-5443.
Quantity in Commerce 55
Distribution Nationwide Distribution
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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