V60 Ventilator, Symbols Only, With Cflex And Avaps Options

Starting date:

February 8, 2017

Posting date:

February 27, 2017

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-62386

• Reason
• Affected products

Reason

The V60 ventilator with version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent INOP) and display error code 100E. Ventilatory support will cease.

An audible high-priority alarm will sound continuously for at least 2 minutes when the V60 shuts down for any vent INOP condition and is operating on battery power. If the V60 is connected to AC power (mains supply), the alarm will continue to sound until an operator intervenes. If the V60 is connected to a remote alarm system, the alarm system will be activated until action is taken by the operator.

Error code 100E only exists in V60 version 2.20 software. Therefore, V60's running version 2.10 software are not subject to this particular vent INOP condition. An audible high-priority alarm will sound continuously for at least 2 minutes when the V60 shuts down for any vent INOP condition and is operating on battery power. If the V60 is connected to AC power (mains supply), the alarm will continue to sound until an operator intervenes. If the V60 is connected to a remote alarm system, the alarm system will be activated until action is taken by the operator.

Error code 100E only exists in V60 version 2.20 software. Therefore, V60's running version 2.10 software are not subject to this particular vent INOP condition.

Affected products