FAQ about the Philips Respironics™ Devices Recall R2109

VitalAire Canada Inc. has been informed by medical device manufacturer Philips Respironics that some of its devices equipping patients with respiratory diseases treated at home may present a potential safety issue with one of the components (sound abatement foam). For more details on the recall and the safety issue, please refer to our Patient Brochure:

On June 14, 2021, medical device manufacturer Philips Respironics issued a Field Safety Notice regarding the recall of respiratory and ventilator devices due to the health risks associated with their use. Full details of the recall are available on the Philips Respironics website. 

Please see full list of affected models below:

Continuous Ventilator, Minimal Ventilatory Support, Facility use

• E30

Continuous Ventilator, Non life supporting - BiPAP

• DreamStation ASV
• DreamStation ST, AVAPS
• SystemOne ASV4
• C-Series ASV
• C-series S/T and AVAPS
• OmniLab Advanced +

Non-continuous ventilator

 

CPAP

• SystemOne (Q-series)
• DreamStation 
• DreamStation Go
• Dorma 400
• Dorma 500 
• REMstar SE Auto

Continuous Ventilator

• Trilogy 100
• Trilogy 200
• Garbin Plus, Aeris, LifeVent

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

• A-series BiPAP Hybrid A30 
• A-series BiPAP V30 Auto

Continuous Ventilator, Non-life Supporting

• A-series BiPAP A40
• A-series BiPAP A30

The recall does not impact any other devices distributed by VitalAire Canada Inc. including the ResMed devices.

The recall does not impact the following Philips Respironics devices:

• Trilogy Evo
•  Trilogy Evo OBM
• Trilogy EV300
• Trilogy 202
• BiPAP A40 EFL
• BiPAP A40 Pro
• M-Series
• DreamStation 2
• Omnilab (original based on Harmony 2)
• Dorma 100, Dorma 200, & REMStar SE
• All oxygen concentrators, respiratory drug delivery products, airway clearance products

We are registering with Philips Respironics the serial numbers of all affected devices sold by VitalAire Canada Inc., on behalf of our patients and clients, to ensure they are taken into consideration as part of the repair/replacement program under development by Philips Respironics.

We require that our patients acknowledge they are aware of the recall and provide us with critical information to schedule the repair or replacement of their device. Please fill in the form online by September 1, 2021

Acknowledge Here

Affected devices will either be replaced with a new or repaired unit that incorporates new material, or be repaired. Considering the scope of this worldwide recall, please expect a delay before devices can be repaired or replaced. In addition, this situation has also strained the pool of loaner devices and, until further notice, there are no more devices available to be loaned/rented to patients.

As we receive further information from Philips Respironics on its repair/replacement program, we will contact our patients and clients regarding their devices to ensure the appropriate settings of their new or repaired equipment and to assist them throughout this process.

We understand the impact of this situation on our patients’ therapy and it is our priority to support them at all times. However, Philips Respironics repair/replacement program will take some time to be put in place pending the repair process for existing devices regulatory approval by Health Canada. 

Upon this approval, Philips Respironics should then be able to initiate its repair/replacement process, and we will work with this manufacturer to deploy it with our patients and minimize inconveniences. 

To allow us to optimize our interaction with patients, we kindly ask our patients and clients to limit the number of calls to our dedicated Recall Helpline.

Since we do not yet have specific instructions from Philips Respironics, we would request that our patients and clients wait for the repair/replacement program to be launched and instructions from VitalAire Canada Inc. before bringing any equipment to our clinics.

We have already initiated the process by registering the serial numbers of our patients and clients’ affected devices serial numbers on Philips Respironics dedicated platform. We will update our website and inform our patients and clients once further instructions are communicated by Philips Respironics.

Most of the relevant learned medical associations for respiratory diseases, along with health authorities around the world, recommend continuing treatment, regardless of the type of device, and consulting a physician.

The Canadian Sleep Society is recommending an individualized decision after discussion with the physician when an alternative device can’t be secured in a timely manner. For the sake of our patients and clients’ safety, we recommend they seek medical advice regarding their treatment continuum.

Neither the patient nor the healthcare professionals should try to remove the foam themselves.  Any action related to device repair should only be conducted by an individual that is duly trained and authorized by Philips and using specific procedures.  In addition, we cannot confirm what other implications tampering with the device may have. The repair/replacement program is still under development by Philips Respironics and should include the appropriate instructions to follow.