Philips V60/V60 Plus Ventilators (2021-06-21)

Starting date:

June 21, 2021

Posting date:

June 30, 2021

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-75939

Last updated:
2021-06-30

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  Reason
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  Affected products

Affected Products 

A. V60 VENTILATOR, SYMBOLS ONLY, WITH FLEX AND AVAPS OPTIONS

B. RESPIRONICS V60 PLUS VENTILATOR

Reason

The V60/V60 Plus ventilators equipped with High Flow Therapy option (Software Version 3.00 and Software Version 3.10) are designed with a safety mechanism to limit the amount of pressure that can be delivered to the patient when the ventilator is operating in High Flow Therapy. In situations where the high flow therapy pressure reaches the maximum limit, the ventilator will sound a low priority alarm and reduces the pressure – which also simultaneously decreases the flow rate to a level below what was set by the clinician. In some cases, patients may experience oxygen desaturation as a result of the decrease in flow rate, which can be characterized as moderate or severe hypoxemia.

Affected products