Philips Respironics Recall Notice & Updates
MAGNET MASK RECALL - Updated as of 9/9/2022
9/9/2022: Philips Respironics issued a medical device correction for their masks with magnets, affecting the Amara View Minimal Contact Full Face Mask, DreamWear Full Face Mask, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks and Wisp Youth Nasal Masks, and Therapy Mask 3100 NC/SP.
Philips, in partnership with the FDA, has issued this notification and FAQ to make consumers aware that the company is updating their existing Contraindications and Warnings with these above-mentioned masks in the labeling currently provided. While Philips updates these labels, they have directed us to keep these items on a shipping hold until further notice. At this time, there is no ETA on when will begin shipping the above-mentioned masks again.
MACHINE RECALL- Updated as of 9/1/2021
9/1/2021: Philips Respironics issued a press release indicating that the repair and replacement program of first-generation DreamStation devices in the US has started, and that the new sound abatement foam has been approved by the FDA. Philips Respironics intends to complete the repair and replacement programs within approximately 12 months.
8/12/2021: Philips Respironics provided supplemental clinical information for the use of bacteria filters.
7/29/2021: The US Food & Drug Administration (FDA) develop and publish a Philips Respironics Recall FAQ.
7/8/2021: Philips Respironics provided supplemental clinical information for physicians regarding the recall.
6/28/2021: The DME MACs, who process Medicare Durable Medical Equipment, Orthotics, and Prosthetics (DMEPOS) claims for a defined geographic area/jurisdiction, develop and publish a Philips Respironics Recall FAQ.
6/14/2021: On June 14, 2021, Philips Respironics issued a voluntary recall notification for their Continuous Positive Airway Pressure (CPAP) and Bi-level Positive Airway Pressure (BiPAP) machines due to potential health risks related to the sound abatement foam used in their respective devices.
Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. They have established a registration portal and support center to assist you.
If Nationwide Medical, Inc. supplied you with your machine, we submitted your device information to Philips Respironics to start the registration process.
However, your action is still required; Philips Respironics requires that each patient registers directly in order to process the replacement device.
Submit your registration online or call (877) 907-7508.
You will need to provide your device serial number and current contact information.
Although we are not responsible for the Philips Respironics recall, we want to support our patients through this difficult time. We have been working diligently with Philips Respironics to ensure our patients receive continual updates. As we learn more, we will update our website here. Or, contact us to learn more.
Call Us at (888) 969-3052
Email Us at PatientServices@nationwidemedical.com
Live chat on our website www.nationwidemedical.com
Nationwide Medical, Inc.