Health product recall

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

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

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

Lot or serial number

All lots.

Model or catalog number

1053614

Companies
Manufacturer

Respironics California LLC

2271 Cosmos court

Carlsbad

92011

California

UNITED STATES

B. RESPIRONICS V60 PLUS VENTILATOR

Lot or serial number

All lots. 

Model or catalog number

1137276

Companies
Manufacturer

Respironics California LLC

2271 Cosmos court

Carlsbad

92011

California

UNITED STATES