Philips Respironics, a subsidiary of Royal Philips, has recalled certain CPAP or Bi-Level PAP therapy masks with magnetic components due to a serious safety concern.
The company said that the masks are not advised for use near patients using respiratory devices, their family members, caregivers and others, with metallic devices or objects implanted in their body.
Worn by patients using BiPAP or CPAP devices, the masks contain magnetic clips to connect the headgear straps.
When used close to patients with implanted devices, the magnetic components of the masks may impact the implants, causing potential injuries or death, said the company.
Philips Respironics urged patients with contraindicated implants or medical devices to stop using the magnetic mask, and consult their physician immediately for an alternative.
In addition, the company also suggested the patients switch to a non-magnetic mask to continue their treatment.
Philips Respironics, in its statement, said: “This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labelling.
“All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.”
The US Food and Drug Administration (FDA) alerted caregivers and health care providers regarding the voluntary recall of the devices.
Philips Respironics said that it has distributed more than 17 million masks containing magnetic clips, to date.
It has received 14 reports suggesting that the mask magnets may have impacted the patients’ medical devices, as of 30 August 2022, said the company.
The impacts include pacemaker interference, pacemaker failure, shunt adjustment, resetting of AICD, seizures, defibrillator failure, arrhythmia, irregular BP, heartbeats, and cognitive issues.
Last month, Philips recalled a few of its bi-level positive airway pressure Bi-level PAP (BiPAP) machines due to plastic contamination.
According to the US FDA, the plastic used in the machines may contain a non-compatible material that could leak harmful chemicals, known as volatile organic compounds (VOCs), if placed in the device’s motor.
