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Frequently asked questions

Recall of masks containing magnets from Philips

1. Who is affected by this recall?

See the Who is affected page.

2. Which masks are affected by this recall?

See the Affected masks page.

3. What should I do if I am affected by the recall?

See the Replacement Procedure page.

4. Why are Resmed and Fisher & Paykel masks not being recalled?

The magnetic strength of the Resmed masks' magnets is less than that of Philips' and does not affect metallic medical devices in the same way. The current manufacturer's warnings state to keep magnetic clips at least 2 inches (50mm) away from active medical devices, which is safe.

Fisher & Paykel masks do not have magnets.

5. What is a Contraindication versus a Warning?

A contraindication is a condition under which the device should not be used because the risk of use clearly outweighs any possible benefit. A warning alerts the patient about a situation which, if not avoided, could result in death or serious injury. Additionally, a warning may also describe potential serious adverse reactions and safety hazards. In short, a contraindication tells the user when a device should not be used, and a warning tells the user how to avoid sources of harm in the use of the device.

6. Are Philips Respironics masks with magnetic headgear clips safe?

Yes, these masks are safe to continue to use according to the updated instructions and labeling if patients or bystanders do not have metallic implanted medical devices or metallic objects in their bodies.

Magnetic headgear clips are used to secure the headgear straps to the mask, which is a common method used in the sleep therapy device industry. Such magnetic clips are also used in the wearable electronics industry.

7. What is the relative strength of each clip (in millitesla)?
  • Philips: Magnets with a magnetic field strength up to 400 mT (millitesla) are used in the Philips mask.
  • Resmed: The magnetic force of the clip is between 250 mT (millitesla) and 270 mT, which is within the allowable safety limit of 400 mT.

The strength of the magnet should not deteriorate over time under normal use.

8. Why do I need to keep the magnetic clips more than 6 inches (15 cm) from my active medical devices?

There are different types of active medical devices. Magnets may interact differently with each type of device. In general, if a magnet is brought too close to the device, the device will temporarily go into "default mode". However, the device should return to normal operation once the magnetic field is far enough away from the device.

9. Will manufacturers continue to distribute masks with magnetic clips?

Yes, after implementation of the updated instructions and labeling, manufacturers will continue to distribute masks with magnetic clips.

10. What is the potential risk of serious injury that Philips Respironics is warning about?

More than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date. As of September 2022, Philips Respironics has received 16 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.

11. Do I need to take any special steps to care for and maintain the magnets?

No additional steps are required beyond normal mask care. For home use, leave the magnets attached to the headgear and wash them once a week by soaking and agitating them in warm water with a mild liquid detergent for up to 10 minutes. For more information, please refer to the product's user guide.