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Medical Device recall notification (U.S. only) / field safety notice (Outside of U.S.)

Philips Respironics

There is nothing we take more seriously than providing patients with high quality products that are safe and reliable. If an issue arises, we are proactive in communicating and addressing it as we work tirelessly towards a resolution.

In Hong Kong, the correction action plan has been underway since September 2021. Philips intends to complete the repair and replacement programs within approximately 12 months.
 

On April 26, 2021, Philips provided an important update regarding proactive efforts to
address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.

At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in
specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive
Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The company
also indicated that analysis of potential health risks was ongoing, and that
further information would be provided when available.

As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) *for specific affected devices.

In Hong Kong market, the notification* informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.  High heat and high humidity environments may also contribute to foam degradation in certain regions.

The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which we operate.

In Hong Kong market, the notification* advises patients and customers to take the following actions:

 

  • For patients using BiPAP and CPAP devices:
    Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
  • For patients using life-sustaining mechanical ventilator devices:
    DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.


Philips is recommending that customers and patients do not use ozone-related cleaning products.


Additionally, Philips is reminding customers and patients to review the age of their BiPAP and CPAP devices, as they are recommended to be replaced after five years of use.

We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible.

The company has developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. In Hong Kong, the correction action plan has been underway since September 2021. Philips intends to complete the repair and replacement programs within approximately 12 months.

In Hong Kong market, to enquire about the Medical Device recall notification (U.S. only) / field safety notice (Outside of U.S.)* and to obtain useful information for impacted customers, users, and physicians, please call Sleep and Respiratory Care hotline at (852) 2873 1232. Customers of Philips Sleep and Respiratory Care authorized distributor in Hong Kong, Celki VitalAire, please click here for relevant information. For relevant global information, please visit www.philips.com/src-update

What you need to do

 

Philips is committed to rectifying this issue through a robust and comprehensive repair and replacement program.

In Hong Kong, the correction action plan has been underway since September 2021. Philips intends to complete the repair and replacement programs within approximately 12 months.

Icon Business

Durable Medical Equipment Providers, Distributors, or Medical Institutions​

 

In Hong Kong market, to enquire about the Medical Device recall notification (U.S. only) / field safety notice (Outside of U.S.)* and to obtain useful information for impacted customers, users, and physicians, please call Sleep and Respiratory Care hotline at (852) 2873 1232. Customers of Philips Sleep and Respiratory Care authorized distributor in Hong Kong, Celki VitalAire, please click here for relevant information. For relevant global information, please visit www.philips.com/src-update.  

 

Icon Patient

Patients, Users, or Caregivers​

 

In Hong Kong market, to enquire about the Medical Device recall notification (U.S. only) / field safety notice (Outside of U.S.)* and to obtain useful information for impacted customers, users, and physicians, please call Sleep and Respiratory Care hotline at (852) 2873 1232. Customers of Philips Sleep and Respiratory Care authorized distributor in Hong Kong, Celki VitalAire, please click here for relevant information. For relevant global information, please visit www.philips.com/src-update

Icon Medical professional

Physicians and other medical care providers​

 

Click the link for additional clinical details on the issue and other information to help you advise your patients who have been impacted.

What devices are affected by the recall notification / field safety notice*?

 

The recall notification (U.S. only) / field safety notice (Outside of U.S.)* provides customers with information on how to identify affected products.


Additionally, the device Instructions for Use provide product identification information to assist with this activity.


Products listed in this notification* include:

CPAP and BiPAP Devices

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30

E30

(Emergency Use Authorization)
(Not sold in HK)

Continuous Ventilator, Non-life Supporting

DreamStation ASV

DreamStation     

ASV

DreamStation AVAPS

DreamStation

ST, AVAPS

60 Series CPAP, ASV

SystemOne

ASV4

C Series AVAPS/ST

C Series 

ASV, S/T, AVAPS

OmniLab Advanced Plus(sleep lab) CPAP

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

60 Series CPAP, ASV

SystemOne

(Q series)

DreamStation CPAP

DreamStation

CPAP

DreamStation Go

DreamStation GO

CPAP & APAP
(DreamStation Go CPAP not marketed in HK)

Dorma 400, 500

Dorma 400, 500 CPAP

(Dorma 400 not marketed in HK)

REMStar SE Auto CPAP

REMStar SE Auto

CPAP

Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator

Trilogy 100

Trilogy 100

Ventilator

Trilogy 200

Trilogy 200

Ventilator
(Not marketed in HK)

Trilogy 200

Garbin Plus, Aeris, LifeVent

Ventilator
(Not marketed in HK)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A 40/30

A-Series BiPAP Hybrid A30

 (Not marketed in HK)

V30

A-Series BiPAP V30 Auto

Ventilator
(Not marketed in HK)

Continuous Ventilator, Non-life Supporting

A 40/30

A-Series BiPAP A40

A 40/30

A-Series BiPAP A30

What products are not affected and why?

 

Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.

  • Trilogy Evo
  • Trilogy Evo OBM (Not marketed in HK)
  • Trilogy EV300
  • Trilogy 202
  • A-Series Pro and EFL (Not marketed in HK)
  • M-Series
  • DreamStation 2
  • Omnilab (original based on Harmony 2)
  • Dorma 100, Dorma 200, & REMStar SE
  • V60 Ventilator
  • V60 Plus Ventilator
  • V680 Ventilator
  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.

Questions and answers

Are affected devices safe for use? Should affected devices be removed from service?

In Hong Kong market, the field safety notice*advises patients and customers to take the following act:

 

  • For patients using BiLevel PAP and CPAP devices: 
    Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. 
  • For patients using life-sustaining mechanical ventilator devices: 
    DO  NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 

 

Philips is recommending that customers and patients do not use ozone-related cleaning products.


Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.

What is the safety hazard associated with this issue? Has Philips received any reports of patient harm due to this issue?

The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.  High heat and high humidity environments may also contribute to foam degradation in certain regions.
 

Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate.


In the event of exposure to degraded foam:

 

  • The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects. 

 

In the event of exposure to chemical emissions:

 

  • The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. 
When will the correction for this issue begin? How long will it take to address all affected devices?

The company will replace the current sound abatement foam with a new material that is not affected by this issue.


At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible.  In Hong Kong market, the correction action plan has started in September, and was expected to complete within 12 months.

Are affected devices continuing to be manufactured and/or shipped?
At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues.
Is this a recall?
The issuance of the notification is a recall in the U.S., and field safety notice in Outside of U.S., according to regulatory agency criteria.
How will Philips address this issue? Are affected devices being replaced and/or repaired? Are customers entitled to warranty replacement, repair, service or other mitigations?

We are treating this matter with the highest possible seriousness, and are working to addressthis issue as efficiently and thoroughly as possible.


As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.


The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. 


Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. The new material will also replace the current sound abatement foam in future products.

 

Philips is recommending that customers and patients do not use ozone-related cleaning products.


Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.
 

The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction.


Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.


For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.

Are there any steps that customers, patients, users and/or clinicians should take regarding this issue?

Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets).

 

The recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. 
  • For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 
  • Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets) website, www.philips.com/SRC-update

The company has developed a comprehensive plan for this correction, and has already begun this process. In Hong Kong market, corrective action plan has begun in September and
is expected to complete within 12 months.

 

Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.

 

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.


Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.

 

For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Call 877-907-7508 if you cannot visit the website or do not have internet access.

What is the cause of this issue? Was it a design, manufacture, supplier or other problem?
Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio.
How did this happen, and what is Philips doing to ensure it will not happen again?

Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue.


The products were developed according to the required standards and regulatory registrations at the time of initial release.  The Philips
Quality Management System has been upgraded to reflect alignment with updated standards. 


The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements.

What is meant by "high heat and humidity" being one of the causes of this issue?

Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature.

 

The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored.

 

This factor does not refer to heat and humidity generated by the device for patient use.

Do affected units exhibit features that customers / users should watch out for? Particles or other visible issues?
Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (Outside of U.S.). 
Is Philips certain that this issue is limited to the listed devices? Is there any possibility others are affected?

Analysis by Philips under the company's Quality Management System has reviewed and identified affected devices that were designed to incorporate the PE-PUR foam.
 

In accordance with the Philips Quality Management System, the company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which we operate.

* 召回通知僅針對美國市場,並作為醫療設備出廠後安全通知對世界其他市場進行通知。在香港,我們已主動向受影響客戶發出「醫療設備出廠後安全通知」

**有關飛利浦睡眠和呼吸護理產品糾正計劃的全球資訊,請瀏覽www.philips.com/src-update

Disclaimer: The Chinese version of this document is a translation of the English version. In case of discrepancy in the two versions, the English version shall prevail.

免責聲明: 本文件為英文版的翻譯,可能存在差異, 請以英文版為準。

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