Recall Z-2667-2016— Vision RT Ltd

Name: FDA recall Z-2667-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-30

Class II · Terminated

Class II FDA medical device recall by Vision RT Ltd, initiated 2016-06-30, terminated 2017-09-20. It names one FDA 510(k) clearance: K123371. Product: AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.. Reason: Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases..

Recalling firm: Vision RT Ltd
Classification: Class II
Status: Terminated
Initiated: 2016-06-30
Terminated: 2017-09-20
Firm location: London, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K123371 — ALIGNRT PLUSVision RT Limited·cleared 2013-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

Reason for recall

Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.

Data sourced from openFDA. This site is unofficial and independent of the FDA.