• On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues concerning a component of certain products from our sleep and respiratory care range.
• At that time, as a precaution and based on available information, Philips reported potential health risks related to the sound abatement foam used in certain Philips continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP) devices, as well as in mechanical ventilators. The company also indicated that the analysis of potential health risks was ongoing and that further information would be provided as soon as it became available.
• Following the ongoing in-depth analysis resulting from this announcement, the company issued a recall notification for certain affected devices on June 14, 2021.
• The recall notification informs customers and users of the potential health impacts on patients and the clinical use associated with this issue. The possible health risks include exposure to degraded sound abatement foam, caused for example by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam. Environments with high heat and humidity may also contribute to foam degradation in certain regions.
• To date, Philips has received a limited number of reports concerning a possible patient impact due to foam degradation, and no reports so far concerning patient impact related to chemical emissions. The company continues to monitor reports of potential safety issues, in accordance with medical device regulations and laws in the markets where it operates.
• The recall notification advises patients and customers to take the following actions:
  • For patients using PAP and BiPAP devices: Stop using the affected devices and consult a physician to determine the benefits of continuing therapy, as well as potential risks.
  • For patients using life-sustaining mechanical ventilator devices: DO NOT stop or alter the prescribed therapy without consulting their physicians to decide on the next steps.
• Philips recommends that customers and patients do not use ozone-based cleaning products and follow the approved cleaning methods specified in their device’s user manual.
• Additionally, Philips reminds its customers and patients to check the age of their PAP and BiPAP devices, as it is generally recommended to replace them after five years of use.
• We take this issue very seriously and are working to resolve it as effectively and comprehensively 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 work on this process.
• For more information on the recall notification, as well as instructions for customers, users, and physicians, concerned parties can contact their local Philips representative or visit philips.com/SRC-update. In the U.S., concerned parties may also call the toll-free number, 877-907-7508.

• The recall notification provides customers with information on how to identify affected products. In addition, the device’s user manual provides information on product identification to facilitate this operation.
• The products affected by this recall notification are as follows:
• Two-level CPAP and PAP devices:
  • All affected devices manufactured before April 26, 2021, all device serial numbers;
• Continuous ventilator, minimal ventilatory assistance, institutional use:
  • E30 (authorization for emergency use)
• Continuous ventilator, without ventilatory assistance:
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C-Series ASV
  • C-Series S/T and AVAPS
  • OmniLab Advanced+
• Mechanical ventilators:
  • All affected devices manufactured before April 26, 2021, all device serial numbers.
• Continuous fans:
  • Trilogy 100
  • Trilogy 200
  • Garbin Plus, Aeris, LifeVent
• Continuous ventilator, minimal ventilatory assistance, institutional use:
  • A-Series BiPAP Hybrid A30 (not sold in the U.S.)
  • A-Series BiPAP V30 Auto
• Continuous ventilator, without ventilatory assistance:
  • A-Series BiPAP A40 (not sold in the U.S.)
  • A-Series BiPAP A30 (not sold in the U.S.)

Products that are not affected may be manufactured with different soundproofing foams, as new materials and technologies become available over time. In addition, the soundproofing foam of unaffected devices may be placed in a different location due to the design of the device.

The products affected by this recall notification are as follows:

1. Trilogy Evo
2. Trilogy Evo
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, and REMstar SE
10. All oxygen concentrators, respiratory drug delivery products, airway clearance products.

The recall notice informs customers and users of the potential health impacts on patients as well as the clinical use impacts related to this issue. The potential health risks include exposure to degraded soundproofing foam, caused by unapproved cleaning methods such as the use of ozone, as well as exposure to chemical emissions from the foam. High heat and high humidity environments may also contribute to foam degradation under certain conditions.

Philips continues to monitor reports of potential safety issues through its post-market surveillance activities, in accordance with medical device regulations and laws in force in the markets where the company operates.

In case of exposure to degraded foam:

The potential risks of exposure to degraded foam are as follows: irritation (skin, eyes, and respiratory tract), inflammatory reaction, headache, asthma, adverse effects on other organs (e.g., kidneys and liver), and carcinogenic toxic effects. To date, Philips Respironics has received several complaints about the presence of black debris/particles in the air circuit (from the device outlet, humidifier, tubing, and mask). Philips has also received reports of headaches, irritation of the upper respiratory tract, cough, chest pressure, and sinus infection.

In case of exposure to chemical emissions:

The potential risks of exposure to chemical emissions from the affected foam are as follows: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. To date, Philips has not received any reports of patient consequences or serious harm resulting from this issue.

The recall notice advises patients and customers to take the following measures:

– For patients using bi-level PAP and CPAP devices:
Stop using the affected devices and consult a physician to assess the benefits of continuing treatment as well as the potential risks.

– For patients using life-support mechanical ventilator devices:
DO NOT stop or alter the prescribed treatment without consulting a physician to decide on the next steps.

Philips recommends that customers and patients avoid using cleaning products containing ozone and adhere to the instructions for use of their device regarding approved cleaning methods.
Additionally, Philips reminds its customers and patients to check the age of their bi-level PAP and CPAP devices, as it is generally recommended to replace them after five years of use.

For the time being, the devices concerned are awaiting manufacture and shipment, as the company prepares to implement the repair/replacement program for the devices concerned, in order to install new soundproofing foams that are not affected by the problems reported.

• Philips informs the regulatory agencies in the regions and countries where the affected products are available.
• We are providing the agencies with the necessary information relating to the initial launch and ongoing implementation of the planned correction.
  The company will replace the current soundproofing foam with a new material that is not affected by this problem, and has already begun work on this.
• At present, the company is working to process all devices affected by this correction as quickly as possible.

• We take this issue very seriously and are striving to resolve it in the most effective and comprehensive manner. Following an ongoing in-depth analysis, on June 14, 2021, the company issued a recall notice for certain Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP) devices, and mechanical ventilators.

• The recall notice informs customers and users of the potential health impacts on patients as well as the clinical use implications related to this issue. Potential health risks include exposure to degraded sound abatement foam, caused, for example, by the use of unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam.

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

• Philips recommends that customers and patients do not use ozone-containing cleaning products and adhere to the approved cleaning methods outlined in the device’s user manual. Furthermore, Philips reminds customers and patients to check the age of their CPAP and BiPAP devices, as it is generally recommended to replace them after five years of use.

• The company has dedicated significant resources to addressing this issue and has implemented a comprehensive corrective plan, which is already underway. This effort includes a large-scale, global ramp-up of manufacturing, repair, services, supply chain, and other functions to support the corrective action.

• Philips deeply regrets the inconvenience caused by this issue, and we are dedicating considerable time and resources to provide the affected patients and customers with the service they expect and deserve, as resolving this issue is our top priority.

• For more information on the recall notification, as well as instructions for customers, users, and physicians, affected parties can contact their local Philips representative or visit the website com/SRC-update. In the U.S., affected parties can also call the toll-free number, 877-907-7508.

• The issuance of the recall notification corresponds to a recall according to the criteria of the regulatory authorities.
• This recall notification has not yet been classified by the regulatory authorities.

According to Philips’ analysis, the root cause of this problem is linked to the soundproofing foam currently used in certain identified products in the sleep and breathing care range.

Customers, patients, users, and clinicians are encouraged to follow the recommendations contained in the recall notification.

The recall notification advises patients and customers to take the following actions:

– For patients using CPAP and BiPAP devices: Cease using the affected devices and consult a physician to weigh the benefits of continuing treatment against the potential risks.

– For patients using life-support mechanical ventilation devices: Do not interrupt or modify the prescribed treatment without consulting a physician to determine the next steps.

Please register the affected devices on the recall website, philips.com/SRC-update. The website provides up-to-date information on the status of the recall and how to receive a permanent corrective action to address both issues. It also offers instructions on how to find the serial number of an affected device and guides users through the registration process.

In the United States, call the troubleshooting line at 877-907-7508 if you cannot access the website.

The company has implemented a comprehensive correction plan, which has already begun to be applied. Philips recommends that customers and patients do not use cleaning products containing ozone and adhere to their device’s user manual regarding approved cleaning methods. Additionally, Philips reminds its customers and patients to check the age of their CPAP and BiPAP devices, as it is generally recommended to replace them after five years of use.

Philips deeply regrets the inconvenience caused by this issue and is dedicating significant time and resources to provide the service that affected patients and customers expect and deserve, as resolving this issue is our top priority.

For more information regarding the recall notification and instructions for customers, users, and physicians, concerned parties can contact their local Philips representative or visit the website philips.com/SRC-update. In the United States, concerned parties can also call the toll-free number, 877-907-7508.

• Philips has discovered that the foam can degrade under certain circumstances due to factors such as the use of unapproved cleaning methods, such as ozone*, and certain environmental conditions involving high humidity and temperature.

• The environmental conditions that may contribute to this problem are related to the climate and regional temperatures of the countries where the devices are used and stored.

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

  *Potential risks associated with the use of ozone-based products and ultraviolet (UV) rays for cleaning CPAP devices and accessories: FDA safety communication.

• Philips has a robust quality management system and has followed our control and analysis processes to identify and resolve this issue.
• The products were designed according to the appropriate standards, and in compliance with those standards, when they were brought to market. As new standards are established, they require an evaluation of product properties according to quality and regulatory processes. Philips’ quality management system has been updated to reflect these new requirements.
• However, although the standards have been updated, products manufactured under the previous standard remain compliant with medical device regulations. Issues related to foam degradation and chemical emissions were discovered as part of our quality management system processes and are being addressed in accordance with the relevant regulatory requirements.
  Philips fully complied with the relevant standards at the time of product marketing.

• Affected devices may be repaired under warranty.
• Philips will provide further information regarding warranty replacement procedures during the course of this problem when it becomes available.

Users should consult their doctor, following the instructions given in the recall notice.

• At this time, Philips is not in a position to install new patients on the affected devices. Philips may work with new patients to provide other potential devices.
• Philips may repair/replace ventilation units on which patients depend in emergency situations, such as device failure during required treatment, to ensure continuity of care.
  Philips PPCs cannot be replaced while the vessel is laid up.