Dear CHOP Patients and Families,

We are reaching out to Children’s Hospital of Philadelphia (CHOP) Care Network patients and families to share important information about a recent recall of certain sleep and respiratory care devices initiated by Philips Respironics. According to CHOP medical records, you or your child may be using one of these devices.

Background: On June 14, 2021, Philips Respironics announced an urgent voluntary recall of their CPAP/BiPAP and mechanical ventilator devices. As of June 30, 2021, the FDA provided a Medical Device Safety Communication detailing the recall for the devices identified below (see “Affected Products”). The recall was prompted by two (2) issues related to the sound abatement foam used in these devices:

1. The foam may degrade into particles, which may enter the device’s air pathway and be swallowed or inhaled by the user, and
2. The foam may “off-gas,” or release certain chemicals into the air during operation, which may expose the user to chemicals being released from the foam material.

The breakdown of the foam may increase with unapproved cleaning methods, such as the use of ozone cleaners. The breakdown may also increase in high heat and high humidity environments.

Risk: According to Philips Respironics, these issues can result in serious injury which can be life-threatening, cause permanent damage to the user and/or require medical care to avoid permanent health problems.

Potential health risks from exposure to degraded foam include:

• irritation to the skin, eyes and lungs
• swelling
• headache
• asthma
• damage to kidney or liver
• risk of cancer

Potential health risks from exposure to the release of chemicals into the air from affected foam include:

• headache/dizziness
• irritation of eyes, nose, lungs and skin
• nausea/vomiting
• chemical poisoning
• risk of cancer

To date, Philips Respironics has received complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing and mask), as well as reports of headache, upper airway irritation, cough, chest pressure and sinus infection.

Recommended Actions: We recommend that you continue using your device in the short term, and that you immediately contact CHOP’s Public Health Resource Line at 1-800-722-7112. They will discuss the recall with you and gather information to send to your provider so that next steps can be arranged.

Because there are clinical situations where the benefit of continued usage outweighs the risks identified in the recall notice, we strongly recommend that patients and families consult with their healthcare team if there are any questions about stopping the use of the device. If you or your child is using an affected life-sustaining mechanical ventilator device, DO NOT stop or alter the prescribed therapy until you have talked to your healthcare team.

Read the full Philips Respironics recall notification letter here. Philips is in the process of implementing a repair and replacement program to address these issues. The company has also established a registration process that allows patients, users or caregivers to look up their device serial number, determine if their unit is affected and obtain current information on the status of the recall. Read the official FDA Safety Communication here.

Affected Products: The following devices are impacted by the recall:

All Devices manufactured before April 26, 2021, All 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

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 US)
• A-Series BiPAP V30 Auto

Continuous Ventilator, Non-life Supporting

• A-Series BiPAP A40
• A-Series BiPAP A30

For more questions or concerns, please call the CHOP Public Health Resource Line at 1-800-722-7112.

Lori Ciardi
Sr. Director, Home Care

Dana Tauber, MD
Sr. Medical Director for Inpatient Pulmonary and Sleep Services

Ursula Nawab, MD
Sr. Medical Director of Patient Safety