November 17, 2021

UPDATE: Philips Repair/Replacement Process

Please see the update below regarding the anticipated Philips repair/replacement process and timelines. Please note that this process hinges on a number of factors (shipping timelines, whether or not you have registered your device, our ability to contact clients, Philips’s inventory, etc.) so continue to anticipate changes as we navigate this process! We appreciate your patience and understanding. For additional FAQ, visit our October 29, 2021 update.

Please do not call us for status updates (timelines, waitlist status, etc.). We will call you when your machine has arrived. Voicemails of this nature will not be returned; our small team simply cannot keep up with the current volume of calls. For inquiries that have not be answered on our website, email recall@truenorthrespiratory.com

Repair vs. Replacement: 

  • DreamStation 1 (DS1) units that are 5 years or newer will be replaced with a DreamStation 2 (DS2).
  • DreamStation 1 units that are 5 years or older + any other model (including BiPAPs) will be repaired. Philips is awaiting Health Canada approval on this process so this will be initiated later.

Important (please read!):

  • Please keep your recalled machine(s) and ALL accessories. Philips will not be replacing accessories (your tube for example.).
  • Register your device; you must be registered to be remediated.
  • If you’ve moved out of territory, please notify us as your process may be different.

Timelines/Details:

  • The shipping process of DS2 replacement machines to Canada, has begun.
  • There is currently a ship hold on these units, but we are hopeful that they will ship shortly.
  • The number of machines that we will receive with each shipment will vary based on the registration status of all medical equipment providers in Canada, as well as Philips inventory. The number we receive will vary with each shipment and will be adjusted/determined by Philips.
  • Machines received by TrueNorth will have a SN/clients attached to them. We will not know whose machines we have, until we have them. Please wait for our call; we will call you as soon as your machine is ready.

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October 29, 2021

UPDATE

Thank you for your continued patience and understanding as we navigate these unforeseen circumstances. We are working with whatever information is available and are waiting for updates from the manufacturer. As soon as we receive anything new, we will update our website and voicemail, and contact clients directly once appropriate.

General Repair/Replacement Update:

  • Start-Date: Philips has not confirmed a start date for this process yet.
  • Timeline: Philips has advised that device users can expect to receive repair/replacement within approximately 12-months from the time that they registered their device.
  • Repair vs. Replacement: we are still awaiting information about which devices will be replaced vs. repaired. In the meantime, keep your recalled device and all of its components and accessories!
  • Process: we are still awaiting information about the process itself. At this time, we do know that Philips will ship devices to TrueNorth Respiratory, and that we will be responsible for preparing, setting, and orchestrating the exchange of a recalled device for a new device. We will contact clients when the time comes!

Health Canada Requirement (Please Respond!):

  • Health Canada requires TrueNorth Respiratory to ensure each device owner has been contacted. In order to confirm that you are aware of this recall, please contact us via one of the methods below, and leave us your name and phone number:
    • Email: recall@truenorthrespiratory.com
    • Voicemail: 867-667-7120 extension 1014
    • Text: 867-335-7120

Recall Voicemail:

  • Due to the high volume of inquiries we continue to receive, we have changed our menu options to provide answers to some of our most frequently asked questions (included below). At this time, we will not be responding to voicemails as any information that is available has been outlined in the voicemail prompts as well as on our website: truenorthrespiratory.com. For question not addressed, please email recall@truenorthrespiratory.com.

FAQ’s

  1. Continued Use of your Recalled Device
    • As CPAP is a prescription therapy, staff at TrueNorth respiratory are not able to offer recommendations about continuing or discontinuing use. Philips has recommended that you speak with your physician to evaluate the benefits of treatment versus the risk of exposure, with the context of specific patient conditions, to determine the most appropriate care plan. Philips has also recommended to discontinue use of your device until you are able to consult with your physician.
  2. Registering your Recalled Device
    • Please have your device or serial number ready before beginning the registration process. The serial number is on the bottom of your CPAP machine.
  1. Renting a Different Machine
    • With a large number of our devices affected by the recall as well, we are unable to provide rentals at this time.
  2. Purchasing a Different Machine
    • If your machine is over 5 years old, both Philips and TrueNorth recommend replacing it. Most insurance companies will cover a portion of the cost of a new machine after 5 years.
    • If you have purchased your machine within the last 5 years, the costs for a replacement will likely be out of pocket. We understand this situation is challenging. Thankfully, Philips has confirmed that they will be replacing or repairing all affected units.
    • Competing manufacturers have increased production but are unable to keep up with global demand. As such, we are limited to the number of machines we are able to source and sell to our clients. If you’d like to be added to our waitlist for a new machine, please email recall@truenorthrespiratory.com.
  3. More Information
    • For more information about this recall, a complete list of impacted products, and potential health risks, visit philips.com/SRC-updateor call the Philips support line at 877-907-7508.

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October 18, 2021

UPDATE

Philips has not provided any further updates to the process for repairs and replacement, however, we are requesting clients keep their recalled machines and all components as we have been advised that clients will likely need to return them as part of the process.

As we have had an influx of calls, we have updated our recall line to include answers to some of our most frequently asked questions. Response times for call-backs will remain within 5 business days.

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August 30, 2021

TIMELINE UPDATE

Philips has sent out a notification to all registers clients advising that repairs and replacement could take up to 12 months to be completed.

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August 11, 2021

IMPORTANT UPDATE: CALL TO ACTION

Health Canada Update: Type 1 Recall 

As of today, Health Canada have moved the Philips Respironics recall to a Type 1 Recall. As per Health Canada the definition of a Type 1 Recall is:

Type 1: A situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death.

At this time, there have been no changes to the recommendations on the continued use of the recalled devices. Please follow up with your physician to get further recommendations on the continued use of your recalled device, until the repairs or replacement by Philips can be completed.

As the recall has been moved to a Type 1 Recall, Health Canada requires TrueNorth Respiratory to ensure each unit owner has been contacted. In order to confirm  that you have received a recall letter or email from TrueNorth Respiratory, please reach out to us, as we will continue to follow up until we have connected with each client. You can contact us at any of the following:

  • Email: recall@truenorthrespiratory.com
  • Phone/Voicemail: 867-667-7120 extension 1014
  • Text: 867-335-7120

Please include your name so we can complete the registration process on our end.

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July 21, 2021

PURCHASING NEW CPAP DEVICES

Call for availability.

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July 21, 2021

REPAIR/REPLACEMENT UPDATE

Philips has advised us of the following plans to repair/replace recalled devices:

  • Dreamstation 1 CPAP & Auto units will be replaced with Dreamstation 2 units, as long as there is ample inventory to do so
  • If inventory of Dreamstation 2's run out there is a possibility that Dreamstion 1's will be sent out as replacement
  • Dreamstation 1 BiPAP Auto & Pro's will be repaired
  • All other units affected will be repaired

*This information could be subject to change

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July 9, 2021

POSITION STATEMENT FROM THE CANADIAN THORACIC SOCIETY, CANADIAN SLEEP SOCIETY AND  THE CANADIAN SOCIETY OF RESPIRATORY THERAPISTS

The CTS/CSS/CSRT have released a new position statement regarding the Philips Respironics recall.

"For patients using affected CPAP or Bi-Level devices at night for obstructive sleep apnea, would advise contacting their physician in a timely fashion to decide on the best course of action and continue using their device in the meantime"

"On June 23, 2021 Health Canada posted a medical device recall for the same products. The hazard classification is type II, defined as a situation in which the use of , or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote." 

"The risks of continued use of recalled devices are uncertain, but the number of complaints for particulate-related issues to the manufacturer has been low (3 of 10,000 patients in 2020). No death have been reported."

https://www.csrt.com/wp-content/uploads/CTS_CSS_CSRTPhillipsRecallStatement_final07_09_21.pdf

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July 5, 2021

RECALL NOTIFICATION FOR CANADA

Philips Respironics has updated the wording on it's website to confirm that the issuance of the notification is a recall in the U.S. and Canada, and a field safety notice in International Markets, according to regulatory agency criteria.

  • FROM: Medical Device recall notification (U.S. only) / field safety notice (International Markets)
  • TO: Medical Device recall notification (U.S. and Canada) / field safety notice (International Markets)

As the recommended steps to be taken for a field safety notice are the same as for a recall notification, this change does not alter the steps already recommended on our website (below), as well as in the official notification provided to our clients in writing/via email.
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 June 25, 2021

RECALL FAQ'S

Q - I’ve heard about the recall, what now?
A - Visit www.philips.com/src-update to read about the recall, to learn what to do next and to register your device.

Q – How do I know if my machine is affected?
A – Visit www.philipssrcupdate.expertinquiry.com for a list of the affected devices.

Q - How do I register my device?
A - Visit www.philipssrcupdate.expertinquiry.com and follow the registration process. It gives step-by-step instructions, including how and where to find your serial number.

Q – Where can I find the serial number of my device?
A- The serial number of your device is typically located on the bottom of your machine. If you visit www.philipssrcupdate.expertinquiry.com and begin the registration process, you will be brought to a page that provides images of where the serial number is located for any given device.

Q – Can you register my device for me?
A – We are not able to complete the registration process for our clients; please follow the links and direction provided. If you need support, please call the Philips support line at 1-877-907-7508.

Q - Can you tell me if I should be using my device?
A - We are not in the position to offer medical advice or direction on the use of your equipment. Please review Philips Respironics recommendations, and reach out to your physician for further direction.

Q - How can I connect with Philips Respironics directly?
A - To speak to a Philips representative, call 1-877-907-7508.

Q – Can I purchase an inline bacterial filter from you?
A – Both Philips Respironics and The Canadian Sleep Society (CSS) have indicated that the use of the Inline Bacterial Filter is appropriate for use with life-supporting ventilators only (not CPAP or BiPAP). The CSS has made the following statement: ‘In-line bacterial filters can be considered to reduce particulate matter exposure in some devices (Trilogy 100 and 200). The use of these in other devices is unclear due to potential changes in pressure delivery, interaction with the humidifier, etc. Also, the filter will not reduce VOC exposure. Further information regarding the best course of action should be forthcoming from the manufacturer’ (https://css-scs.ca/phillips-respironics-positive-pressure-device-recall). Please email recall@truenorthrespiratory.com directly if you require more information about these filters.

Q - Will TrueNorth Respiratory be issuing refunds or exchanges?
A - All recall and warranty processing will be completed through Philips Respironics directly.

Q – Do you have a loaner or rental machine I can use in the meantime?
A – Unfortunately, due to limited stock we cannot loan or rent machines.

Q - Can I purchase a different CPAP machine?
A - Call for availability.

Q - How has this recall impacted TrueNorth?
A - We value the safety of our clients and this recall has been given priority in our office. As a small team of 8, our clinic is working tirelessly at researching, informing, and managing this recall. Due to the influx of inquiries, our response times may be delayed and our access to new equipment is limited. Rest assured; our office is doing our best to keep you informed while maintaining our availability for client care.

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June 22, 2021

RECALL EMAIL CREATED

As of June 22, we have not received any new or additional information regarding the Philips Respironics recall. We are working with whatever information is available and are waiting for updates from the manufacturer.

Please review the June 18, 2021 update (below) on how to access the official recall notice, a complete list of impacted products, potential health risks and direction on how register your device.

    Unfortunately, we are not in the position to offer medical advice or direction on the use of your equipment at this time. Please reach out to your physician for further recommendation on your therapy.

    Check our website regularly for updates as that is where future communications will be posted. We kindly request that you refrain from calling our clinic with recall inquiries; if you have questions beyond what has been provided on our website, please reach out to our clinic at the following email address: recall@truenorthrespiratory.com. As we expect a large volume of outreach from concerned clients, we will aim to respond within one business week.

    • Your Team at TrueNorth Respiratory

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    June 18, 2021

    WHERE TO FIND INFO / STEPS TO TAKE

    Philips Respironics has announced a voluntary recall (Recall Notification (U.S. only) / Field Safety Notice (International Markets)) for Continuous and Non-Continuous Ventilators (some of their CPAP, BiPAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. A letter will be mailed to all affected clients in the next days.

    Please note: All recall and warranty processing will be completed through Philips Respironics directly via the weblink and/or phone number provided below.

    At this time, Philips Respironics has advised to take the following action:

    1. Register the device with Philips Respironics at the following website: www.philipssrcupdate.expertinquiry.com
    2. Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
    3. Discontinue the use of ozone-related cleaning products such as the SoClean.
    4. Review the age of your BiPAP or CPAP devices, as they are typically recommended to be replaced after five years of use.

    Additional Information:

    • For the official recall notice, a complete list of impacted products, and potential health risks:
    • For support beyond what is posted on the Philips Respironics website:
      • Philips Respironics support line at 877-907-7508
    • For recall inquiries, please reach out to our clinic at the following email address: recall@truenorthrespiratory.com. As we expect a large volume of outreach from concerned clients, we will aim to respond within one business week.
    • Please check our website regularly for updates as that is where future communications will be posted.
    • We kindly request that you refrain from calling our clinic with recall inquiries and follow the communication options provided in this letter.

      Client care and safety are at the core of what drive us at TrueNorth Respiratory. We want to assure you that we are working quickly and diligently to keep you informed as the situation evolves. We are

      • Your Team at TrueNorth Respiratory

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      June 15, 2021 

      RECALL NOTIFICATION

      We have been notified of the voluntary recall of Philips Respironics products. At this time, the recall only applies to devices sold in the USA. We are in contact with our representatives at Philips Respironics and will provide updates and information should this recall affect our clients in Canada. The USA recall notice can be found at http://www.philips.com/SRC-update. If you have questions beyond this notice, call the Respironics support line at 877-907-7508.