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ALIGNRT (2016-07-01)
- Starting date:
- July 1, 2016
- Posting date:
- July 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59616
Affected products
A. ALIGNRT
Reason
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.
Affected products
A. ALIGNRT
Lot or serial number
249-1519
Model or catalog number
ALIGNRT
Companies
- Manufacturer
-
VISION RT LIMITED
DOVE HOUSE, ARCADIA AVENUE
LONDON
N3 2JU
UNITED KINGDOM