Bi-Level PAP and CPAP devices are used by people with respiratory insufficiency or respiratory failure and obstructive sleep apnea.
Worn by patients while using Bi-Level PAP or CPAP devices, the recalled masks use magnetic headgear clips to connect the headgear straps and hold the device in place.
These masks are advised not to be used by or near patients or their family members, caregivers and bed partners who have metallic devices or objects, such as metallic splinters, implanted in their bodies.
The magnets in the masks may affect the functioning or cause movement of certain implanted metallic medical devices, which could result in injury or death of the mask user or nearby people with implanted devices.
The US Food and Drug Administration (FDA) has alerted patients, caregivers and health care providers regarding the voluntary recall of these masks.
Philips Respironics advised patients with contraindicated implants or medical devices to stop using the affected masks and consult their physician immediately to know whether another mask can be used to continue their treatment.
The company also urged users to read and follow its voluntarily updated warning and added contraindication.
To date, the company has distributed more than 17 million masks with magnetic clips.
As of 30 August, it has received 14 reports suggesting that the mask magnets may have impacted patients’ medical devices.
Medical devices that could be affected include magnetic denture attachments, pacemakers, ventriculoperitoneal shunts, implantable cardioverter defibrillators, brain stents, insulin pumps, ocular implants, aneurysm clips and certain neurostimulators.
The DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth, and Therapy masks are all affected by this recall.
In April, Philips Respironics issued a voluntary recall notification/field safety notice to V60/V60 Plus and V680 ventilator customers regarding a potential issue with the ventilators’ electrical circuits.