Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Names:
- Amara View Full Face Mask
- DreamWisp Nasal Mask
- DreamWear Full Face Mask
- Wisp and Wisp Youth Nasal Mask
- Therapy Mask 3100 NC/SP
- Serial and Model Numbers: See recall database entries
- Distribution Dates: January 1, 2015, to September 9, 2022
- Devices Recalled in the U.S.: 18,670,643 units
- Date Initiated by Firm: August 2, 2022
The Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp and Wisp Youth Nasal, and Therapy Mask 3100 masks are worn by a person using bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines to support breathing. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environment.
The recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks.
Reason for Recall
Philips Respironics (Philips) is recalling certain Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp and Wisp Youth Nasal, and Therapy Mask 3100 masks due to a serious safety concern. The recalled masks have magnetic headgear clips to hold them in place. The magnets can potentially cause injury or death if people who use them, or people near a person using a recalled mask, have certain implanted metallic medical devices or metallic objects in the body.
The FDA issued a safety communication, Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices about this topic which includes more information on the types of medical devices and objects that may be affected.
As of September 9, 2022, there have been 43 complaints, 14 of those were serious injuries, associated with this issue. The FDA is not aware of any associated deaths.
Who May be Affected
- People who use the recalled masks
- People near a person using the mask
- Health care personnel providing care for patients using the recalled masks
What to Do
Phillips Respironics issued a press release about this issue on September 6, 2022. The press release offered the following recommendations:
- Stop use of the recalled mask and switch to a non-magnetic mask if available, if the wearer or someone near them when using a recalled mask have any of the implanted metallic medical devices or metallic objects in the body listed that may be affected by the magnets in the masks. The list of devices includes (but is not limited to):
- Implantable cardioverter defibrillators (ICD)
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (that is, neck and head)
- Cerebral spinal fluid (CSF) shunts (such as ventriculo peritoneal (VP) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (such as glaucoma implants, retinal implants)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (such as aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (such as insulin pumps)
- Hypoglossal nerve stimulators
- Devices labeled as MR (Magnetic Resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
- Patients should consult a physician immediately to determine if another mask can be used for their therapy.
- Switch to a non-magnetic mask if available, for continued therapy.
- Dispose of the mask that has magnets after an alternative is obtained.
- Continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.
The FDA’s safety communication Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices offers additional recommendations for health care providers, patients, and their caregivers.
Patients and health care providers with questions may contact Philips Respironics’ customer service at 1-800-345-6443, (Monday – Friday; 8:30 AM ET to 8:00 PM ET) for more information about non-magnetic mask options.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.