V60 VENTILATOR, SYMBOLS ONLY, WITH CFLEX AND AVAPS OPTIONS Serviced With Touchscreen RP Kit 453561511951 (2019-09-18)

Starting date:

September 18, 2019

Posting date:

October 25, 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-71367

Last updated: 2019-10-25

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  Reason
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  Affected products

Affected Products

V60 VENTILATOR, SYMBOLS ONLY, WITH CFLEX AND AVAPS OPTIONS Serviced With Touchscreen RP Kit 453561511951

Reason

If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings.

Affected products