Philips Respironics Recall: June 2021

Philips Respironics Recall: June 2021

 

On June 14, 2021, Philips Respironics announced a voluntary recall of some CPAPs, BiLevel PAPs, and ventilators. This is because of possible health risks related to the sound-proofing foam used in the machines. Learn more

MUHC Philips recall registration form

This registration form is for adult patients who are followed by a doctor at the MUHC for a breathing problem during sleep and who use a Philips breathing device at night.

Register here to be contacted by your doctor or other member of the treating team and to receive updates on the recall as they become available.

Respirologist at the MUHC*
Health Details: Check all the options that apply
Contact & Consent: Check all the options that apply
3 + 11 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Cleaning your CPAP or BiLevel PAP equipment

If you are continuing to use your CPAP or BiLevel PAP machine or using a replacement, it is important to clean it regularly so that it works well. Below are cleaning instructions to follow:

Soap

Do

Don’t

·         Use a mild, non-lotion detergent.

·         We recommend a dishwashing detergent like Ivory Clear, Palmolive, or Dawn.

·         Baby shampoo also works very well.

·         If you are admitted to the hospital, it is OK to use hospital hand soap from the dispenser.

·         Do not use soap or strong dishwashing detergents such as Sunlight.

·         Avoid detergents with strong perfumes or dyes.

·         Do not use ozone or UV light cleaning products to clean your equipment.

 

Water for night use

When you use your equipment, use demineralized or distilled water in your humidifier. If you are admitted to the hospital, it is OK to use sterile water.

 

Cleaning schedule

 

 

Daily

Weekly

Monthly

Yearly

Mask Cushion

Wipe with wet washcloth.

Take apart and wash in a clean sink with warm soapy water.

 Rinse and let air dry.

Inspect for wear and tear.

Replace as necessary.

Replace.

Humidifier Container

Empty and let air dry.

Hose

 

Dust Filter

 

 

 

Rinse (do not use soap) and let air dry.

Replace if not washable.

Machine

 

Wipe exterior with damp cloth.

 

Call supplier to get machine checked.

 

 

 

Philips Recall FAQs

Key points :

  1. The recall affects Philips C-Series machines, SystemOne devices and all DreamStation 1 platforms made between November 2009 and April 26, 2021.
  2. There may be health risks related to using the affected device models.
  3. Philips has said that they are working on a plan for the return, repair or replacement of these devices.
  4. If you have an affected device, register your machine on the Philips website.
  5. Devices from ResMed and Fisher-Paykel are not affected by the recall and can continue to be used safely.

In 2020, Philips Respironics received complaints about the sound-proofing foam for a small number of machines (about 3 in 10 000, or 0.03%). The foam can: 

  • Break down into dust, which could be swallowed or breathed in.
  • Create chemical vapours (a type of gas).

For more information, visit the Philips website. 

The recall includes Philips Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines, and mechanical ventilators made between November 2009 and April 2021. The recall specifically mentions the devices below in the C-Series and all DreamStation 1 platforms:

  • DreamStation Go
  • DreamStation
  • SystemOne
  • DreamStation Expert

Visit the Philips website for a full list of devices and more details.

To see if your device is affected by the recall, find your device’s serial number and use the online device identification tool provided by Philips.

Philips products that are not affected may have different sound-proofing foam materials, as the materials and technologies used change over time. The sound-proofing foam devices may also be in different places in the unaffected machines because of their design.

The Philips products not affected by this recall are listed below:

  • Trilogy Evo
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • BiPAP A40 EFL
  • BiPAP A40 Pro
  • M-Series
  • DreamStation 2
  • Omnilab (original based on Harmony 2)
  • Dorma 100, Dorma 200 and REMStar SE
  • All oxygen concentrators, respiratory drug delivery products and airway clearance products

For more information, visit the Philips website.

Register your machine on the Philips website.

If you use one of the affected BiLevel PAP or CPAP devices, while you wait for a replacement or repaired machine, the MUHC recommends you continue your treatment if one of the situations below applies to you:

  • You have severe trouble breathing or are very sleepy during the day before treatment.
  • You have a major pulmonary (lung), cardiovascular (heart or blood vessel) or neurologic (brain or nerve) condition.
  • You have a job where safety is critical (ex.: professional driver, pilot, or heavy equipment operator).

In any of these cases, the MUHC recommends you continue your treatment because we believe the risks of stopping your treatment are probably greater than the risks from the sound-proofing foam.

Buy a replacement device made by another manufacturer. ResMed and Fisher-Paykel devices do not contain the foam in Philips devices and are considered safe.

If you stop using your Philips device but cannot buy a replacement machine right away, here are some steps you can take to reduce your sleep apnea symptoms and effects:

  • Avoid alcohol or muscle relaxants at bedtime.
  • Keep your head elevated when you sleep (use extra pillows).
  • Sleep on your side (wear a backpack filled with towels).
  • Do not drive for more than 30 minutes without taking a break.

Philips plans to repair or replace the devices affected by this recall. At this time, we cannot say if your device will be repaired or replaced.

The information available right now suggests that it could take as long as a year for your device to be repaired or replaced. Check this page regularly for new updates.

For more information, visit the Philips website.

No. At this time, it is not recommended to do blood tests or lung X-rays if you used a recalled Philips machine.

Call your clinic if you are unwell. Any changes in your respiratory symptoms need to be assessed by your respirology team.

Note that no negative health effects (ex.: infections or being hospitalized) have been reported by Philips to date.

Philips has stated that if foam dust particles are present, they should be large enough to be trapped by a viral/ bacterial filter you can instal on the tubing of your machine. These filters are in addition to the dust filter included in your machine. 

Philips Recall

However, these filters will not stop toxic gas that can also come from the sound-proofing foam.

Unfortunately, these filters can affect the flow of air from the machine and make your treatment not work as well. Because of this, until more information is available, we do not recommend using a filter on your CPAP or BiLevel PAP machine.

If you still choose to use a filter with your machine:

  • Do not add water to your humidifier or use heated tubing. This will cause humidity to clog the filter and reduce airflow from the machine.
  • Inspect your filter every day for build-up of dust or particles. If you see any, replace your filter.
  • Otherwise, replace your filter every 2 to 7 days, based on what the manufacturer of your specific filter recommends.

Do not use a filter for longer than recommended. This could have negative effects on your machine and your health.

IMPORTANT: The information provided is for educational purposes only. It is not intended to replace the advice or instruction of a professional healthcare practitioner or to substitute for medical care.

 

 

 

 

Recalls