Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices.
For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit philips.com/src-update. Affected parties may also call, toll free, 877-907-7508.
FAQ
- 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 and 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), BiLevel 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 for specific affected devices.
- The recall 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.
To date, Philips has received a limited number of reports of possible patient impact due to foam degradation, and no reports to date regarding patient impact related to chemical emissions. 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.
- The recall notification advises patients and customers to take the following actions:
1. 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.
2. 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 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.
- 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.
- 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 philips.com/SRC-update. In the US, affected parties may also call, toll free, 877-907-7508.
- The recall notification 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 affected by this recall notification include:
CPAP and BiLevel PAP Devices
All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
Noncontinuous Ventilator SystemOne (Q-Series)
- DreamStation
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
Mechanical Ventilators
All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers
Continuous Ventilator
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP Hybrid A30 (not marketed in the US)
- A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting
- A-Series BiPAP A40 (not marketed in the US)
- A-Series BiPAP A30 (not marketed in the US)
- 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.
Products not affected by this recall notification include:
1. Trilogy Evo
2. Trilogy Evo OBM
3. EV300
4. Trilogy 202
5. A-Series Pro and EFL
6. M-Series
7. DreamStation 2
8. Omnilab (original based on Harmony 2)
9. Dorma 100, Dorma 200, & REMstar SE
10. All oxygen concentrators, respiratory drug delivery products, airway clearance products.
The recall notification advises patients and customers to take the following actions:
For patients using BiLevel PAP and CPAP devices:
- Discontinue use ofaffected 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 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.
- The recall 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.
- Philips continues to monitor reports of potential safety issues through our postmarket 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 effects.
- To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.
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.
- To date, Philips has not received reports of patient impact or serious harm as a result of this issue.
- Philips is notifying regulatory agencies in the regions and countries where affected products are available.
- We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction.
- The company will replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process.
- At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible.
- 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.
- The issuance of the recall notification is a recall according to regulatory agency criteria.
- This recall notification has not yet been classified by regulatory agencies
- We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible.
- As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
- The recall 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 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.
- 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, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit philips.com/SRC-update. In the US, affected parties may also call, toll free, 877-907-7508.
- Customers, patients, users and clinicians are instructed to follow the guidance
contained in the recall notification.
The recall notification 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 website, philips.com/SRC-update.
1. The website provides current information on the status of the recall and how to receive permanent corrective action to address the two issues.
2. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process.
3. In the US, call 877-907-7508 Service Hotline if you cannot visit the website or do not have internet access.
- The company has developed a comprehensive plan for this correction, and has already begun this process.
- 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 philips.com/SRC-update. In the US, affected parties may also call, toll free, 877-907-7508.
- 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 and Respiratory Care portfolio.
- 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 designed according to, and in compliance with, appropriate standards upon release. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Philips Quality Management System has been updated to reflect these new requirements.
- However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. 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.
- Philips has been in full compliance with relevant standards upon product commercialization.
- 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.
* Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication.
- Users should consult with their physicians as directed in the recall notification.
- Affected devices may be repaired under warranty.
- Philips will provide further information regarding warranty replacement procedures during this issue when it is available.
- At this time, Philips is unable to set up new patients on affected devices. Philips may work with new patients to provide potential alternate devices.
- Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care.
- Philips CPAPs cannot be replaced during ship hold.
- Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers.
- No further products are affected by this issue.