Please see important information from Philips regarding the CPAP recall.
Posted December 6, 2021
December 02, 2021
To our valued customers:
Since we announced a recall of certain products in our Sleep & Respiratory Care portfolio on June 14, 2021, Philips Respironics has been working in close partnership with competent authorities around the world, as well as our customers, clinicians, and patients, to complete the needed repairs associated with this recall.
The U.S. Food & Drug Administration recently provided an update on this recall, having completed an inspection of a Philips Respironics manufacturing facility. The FDA shared its observations from that inspection with Philips, and we are working to respond in accordance with normal practice and timeline.
Importantly, in its observations from the inspection, the FDA has maintained its recommendations related to the continued use of devices for patients and healthcare providers. Philips does not anticipate delay to the recall or replacement program as a result of the FDA report.
Evaluations performed on the silicone-based foam in the DreamStation2 CPAP, repaired DreamStation CPAP/BiPAP devices, and a wide range of mechanical ventilators passed applicable testing. There was one test which the FDA reviewed during its inspection, on a device not currently marketed in the U.S., which is undergoing further analysis. Philips Respironics will also collaborate with the FDA on its request for additional testing.
On Tuesday, Nov. 16, Philips Respironics provided an update to the language included in the recall notifications that have been provided to customers in the U.S. This update aligns the language in the recall notifications to that of the current FDA recommendations. That update can be found at www.philips.com/src-update. For CPAP and BiPAP users, it includes an important update, recommending that they speak with their clinician to determine the risks and benefits of continued therapy on recalled devices. The updated recall notification can be found here.
The previous version of the Urgent Medical Device Recall directed patients to stop use, prior to consulting with their clinician. This update was made to align to the FDA’s recommendations, and to provide clinicians with a wider range of options to consider for each individual patient. The Philips Respironics recommendation for the recall notification on mechanical ventilators remains that patients should not stop or change ventilator use until they have talked to their health care provider.
Philips Respironics continues to focus its resources on the completion of the repair and replacement program. We are encouraged that more than 2 million devices have been registered for the recall by patients in North America, and the pace of our repair and replacement program, which received approval from the FDA on Sept. 1, is accelerating. While we have made progress, we recognize it cannot happen fast enough.
We look forward to sharing additional information with our customers in the days ahead and continuing to partner with you to complete this program.
If you have any questions, please don’t hesitate to reach out to your Philips Respironics representative.
Eline de Graaf
Ad-Interim National Business Leader
Previous Update – July 29, 2021
As you may be aware, on June 14, 2021, Philips Respironics issued a Field Safety Notice regarding the recall of several of its Positive Pressure (CPAP) and Ventilator devices currently on the market due to the health risks associated with their use. Full details of the recall and health implications are available on the Philips Respironics website: www.philips.ca/healthcare.
We have been contacting our clients affected by this recall and have a small sense of the anxiety our clients are feeling. We understand that this recall coupled with the worldwide shortage of alternative CPAP machines have placed many patients and clients with few options. Many have told us that ensuring the continuity of treatment is crucial to their health and wellbeing. In contrast to Philip Respironics’ instructions to discontinue use of the affected devices, we recommend our patients do not discontinue their treatment without seeking advice from their physician first.
Most of the relevant medical associations for respiratory diseases, along with health authorities around the world recommend continuing treatment, regardless of the type of device and first consulting your physician. Specifically, The Canadian Sleep Society states: “we would advise contacting their physician in a timely fashion to decide on the best course of action and continuing using their device in the meantime.” https://css-scs.ca/position-statement-from-the-canadian-thoracic-society-canadian-sleep-society-and-the-canadian-society-of-respiratory-therapists-philips-respironics-device-recall/
Kingston Oxygen regrets the hardship all our clients and patients find themselves facing. We are monitoring the daily and will share any useful information as it becomes available.
Rest assured, we have registered each unit affected by this recall with Philips Respironics, on behalf of our patients and clients. Phillips Respironics has been provided the serial numbers of all affected devices sold by Kingston Oxygen and will hopefully be contacting you directly with a plan to repair or replace each unit. Unfortunately, at this time, no timeline has been offered by Phillips Respironics for their repair/replacement program.
Previous UPDATE – July 5, 2021
On June 14, 2021, Kingston Oxygen received notification that most CPAP machines and certain BiLevel PAP and ventilators manufactured by Philips Respironics were being recalled. Since then, Kingston Oxygen has been in contact with Philips Respironics directly and has forwarded all serial numbers and customer contact information directly to Philips Respironics. Those patients affected by this global recall should expect to be contacted directly by Philips Respironics.
In the meantime, we again strongly recommend using an alternate PAP device if available. Before discontinuing your PAP therapy, seek medical advice.
Continue to refer to our website for further updates as they become available.
Previous Update – JUNE 17, 2021
Important information regarding certain CPAPs, BiLevel PAPs, and ventilators manufactured by Philips Respironics. Details below.
Kingston Oxygen received notification on June 14, 2021 that Philips Respironics had issued a voluntary recall and safety notice for specific Phillips CPAP, BiLevel PAP and Ventilator Devices due to issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices.
Our patient’s safety is our utmost concern. For more information please review the announcement on the Philips Respironics website philips.com/src-update.
We recommend you discuss your Sleep Therapy with your physician regarding continuation of your therapy. Kingston Oxygen Staff will be contacting our affected patients as more information becomes available.