UPDATE – September 6, 2022
Product Alert: Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. Use the links below to find out more about this alert.
UPDATE – September 28, 2021
We continue to monitor the CPAP recall enacted by Philips/Respironics earlier this year. All devices provided through our organization have been reported to Philips per their request. They have announced plans to either repair or replace devices and they estimate this process may take up to 12 months. As of 9/28, Philips reported the FDA had initially approved product design however, they are still awaiting formal approval via the FDA, which is needed prior to repairs taking place. Some users of older devices MAY receive a replacement device directly from Philips. We do no have any additional information from Philips regarding a timeline for our patients. For additional information please refer to our previous announcements or visit this page on the Philips website for full details. We fully understand the challenges and frustration our patients face in dealing with this recall. Please know we are working with Philips to the best of our ability, and we are in contact with alternative suppliers to manage our CPAP program going forward
UPDATE – July 8, 2021
We understand that many of you are concerned about continuing to use your affected CPAP machine during this recall period. While Philips has not yet informed us of their timeline to provide repairs or replacement machines, we continue to communicate with the medical community and monitor the industry for updates and recommendations. Recently The Temple University Lung Center and the Lehigh Valley Health Network have both recommended continued use of CPAP therapy as follows:
“If you have any of these conditions:
- Symptomatic obstructive sleep apnea
- Obstructive sleep apnea and cardiopulmonary disease
- The need for treatment to maintain a commercial driver’s license
The health risks associated with discontinuing CPAP therapy for patients with these conditions outweigh the potential safety hazards currently reported by Philips associated with the recalled products.”
We will continue to provide additional updates as they become available. For more information you may contact Philips directly at 877-907-7508.
Update: June 22, 2021
Philips/Respironics has announced a process for registering devices affected by their filed safety
recall for certain CPAP and ventilator devices. We are working with Philips to ensure all devices
provided through our organization are properly registered so that the process moves forward
as smoothly as possible. Philips assures us that all communications regarding these devices will
come directly to the end-user.
Individuals are welcomed to begin their own registration process by following the inquiry form
found here. If your device is registered through our company and by you individually, Philips
again assures us they will be matching their files to ensure you receive the necessary
documentation including instructions on repairing or replacing your device.
We will do our very best to keep you updated as we learn more regarding this recall. If you would like to contact
Philips directly, they can be reached at 877-907-7508.
More information regarding this recall can be found below.
On Monday, June 14, 2021. Philips Respironics announced a product recall for certain CPAP devices:
Philips has announced a recall for certain CPAP machines based on discovery of potential health risks related to sound abatement foam used in the devices. They have received reports of fine particles and/or traces of chemicals that may be released into the machine’s airway system coming from the foam used for sound abatement. This is more likely for machines used in warm, humid areas AND/OR when ultrasonic or ozone cleaners are used (SoClean). The full details of the recall can be found here.
Should customers continue to use their recalled CPAP?
Philips recommends that patients discontinue use of their device and contact their healthcare provider regarding the benefits and risks involved with continuing sleep therapy using these devices. More information including frequently asked questions can be found here.
How does this impact patients going forward?
Those using certain Philips/Respironics CPAP machines will have their machines either repaired or replaced by the manufacturer. This recall does NOT INCLUDE the new Dreamstation 2 CPAP.
When will this happen?
No date has been offered yet by the manufacturer but we will make EVERY EFFORT to keep our customers informed when we receive more information.
What are we doing in the interim with new patient set-ups?
We are continuing to set-up new patients using a CPAP that was NOT impacted by the recall. We are also working with other manufacturers to secure additional equipment to ensure we can meet the needs of all customers.
Please know that we are committed to doing all we can to manage this manufacturer recall. Feel free to contact us with any questions.
Todd Kinzinger, CRRT