Product Wiki · Recalls · Health Canada — Medical Devices

V60 Ventilator, Symbols Only, with CFLEX and AVAPS Options… — recall 59673

Health Canada — Medical Devices · Canada · 2019-10-03 · Type II

As described by Health Canada — Medical Devices: V60 Ventilator, Symbols Only, with CFLEX and AVAPS Options (2019-09-18)

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Agency
Health Canada — Medical Devices
Recall identifier
59673
Date of alert
2019-10-03
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The touchscreen must be used to change certain therapy settings. The touchscreens in affected units may become frozen and fail to respond to touch commands. Consequently, if a patient requires a change in a ventilator therapy setting, e.g., FIO2, the change could not be made. Although it would be immediately apparent to the user that the changes cannot be made, there is no advance warning of touchscreen failure.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/v60-ventilator-symbols-only-cf

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