FDA-Device2016-08-31Class II
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.
Vision RT Ltd
Hazard
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.
Sold states
Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom. No product was distributed to US government accounts.
Affected count
47
Manufactured in
Dove House, Arcadia Avenue, London, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2667-2016Don't want to check this manually?
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