V60 Ventilator, Symbols Only, with CFLEX and AVAPS Options (2019-09-18)

Starting date:

September 18, 2019

Posting date:

October 3, 2019

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-71145

Last updated: 2019-10-03

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  Reason
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  Affected products

Affected Products

V60 Ventilator, Symbols Only, with CFLEX and AVAPS Options

Reason

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.

 

Affected products