Product Wiki · Recalls · Health Canada — Medical Devices

ALIGNRT (2016-07-01) — recall 55571

Health Canada — Medical Devices · Canada · 2016-07-29 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55571
Date of alert
2016-07-29
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Vision RT has been notified that unintended changes can be made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Vision RT's AlignRT device prior to treatment with Varian's TrueBeam radiotherapy delivery system [TrueBeam]. Neither Vision RT nor Varian received any report of patient harm due to this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/alignrt-2016-07-01

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