Frequently Asked Questions about the Philips Respironics Devices Recall R2109

1. Why is Philips Respironics recalling certain devices?

Respiratory Therapy Specialists 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).

 

2. What devices are affected by the recall?

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 Respiratory Therapy Specialists Inc. including the ResMed devices.

 

3. What Philips Respironics products are not affected?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

 

4. How do I register my device? 

We are registering with Philips Respironics the serial numbers of all affected devices sold by Respiratory Therapy Specialists 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.

 

5. Will affected devices be repaired or replaced?

Affected devices will either be replaced with a new or repaired unit that incorporates new material, or be repaired.

Once 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.

 

6. When will I receive my new device? When will my device be repaired?

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 may take some time to be put in place as the repair process for existing devices requires regulatory approval in 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.

 

7. Should I bring back my Philips Respironics device into one of your clinics for repair/replacement? 

Since we do not yet have instructions from Philips Respironics, we would request that our patients and clients wait for the repair/replacement program to be launched and instructions from Respiratory Therapy Specialists 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.

 

8. Should I stop using my recalled Philips Respironics CPAP device? 

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.