Product Wiki · Recalls · Health Canada — Medical Devices

TRILOGY (100) VENTILATOR SYSTEMS (2016-01-14) — recall 54892

Health Canada — Medical Devices · Canada · 2016-02-08 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54892
Date of alert
2016-02-08
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: Trilogy Ventilators with software versions 13.2.04, 13.2.05, 14.0.00 or 14.1.01 are susceptible to an inadvertent change between prescriptions. This may occur under a particular set of operating conditions and after a specific sequence of key presses without requiring confirmation of the change by the user. Affected devices continue to accurately display the active prescription in the upper left hand corner of the display. As this prescription change was unintended and no confirmation was required, the user may be unaware of this change.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/trilogy-100-ventilator-systems

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