Product Wiki · Recalls · Health Canada — Medical Devices

Oncentra External Beam/Oncentral Brachy 4.5 — recall 44404

Health Canada — Medical Devices · Canada · 2017-01-12 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
44404
Date of alert
2017-01-12
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: If a physical wedge, for which the total field size limit perpendicular to the wedge direction is more than 10 cm larger than the field size limit in wedge direction, is inserted in in-plane direction (as seen with collimator angle 0 degrees), then with very large fields perpendicular to wedge direction a part of the scattered fluence can become unmodulated by the wedge. This will result in profile "horns" close to the edge of the field.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/oncentra-external-beamoncentra

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