AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radios

FDA device recall Z-0464-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Vision Rt Inc

Reason for recall

Potential failure of AlignRT to assert interlock.

Action taken

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.

Root cause

Software in the Use Environment

Status

Terminated

Product code

IYE

Quantity affected

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.

Date initiated

2014-10-15

Date posted

2014-12-16

Date terminated

2016-05-10

Location

Columbia, MD

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