AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a pati

FDA device recall Z-0934-2015 · posted 2015-01-07 · Terminated

Recall details

Recalling firm

Vision Rt Inc

Reason for recall

Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

IYE

Quantity affected

55

Distribution

Nationwide Distribution

Date initiated

2014-11-11

Date posted

2015-01-07

Date terminated

2016-05-11

Location

Columbia, MD

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