Philips Respironics announced a Voluntary Medical Device Recall Notification for Continuous and Non-Continuous Ventilators (certain CPAP, Bilevel PAP and Ventilator Devices) informing 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 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.
What devices are affected by the recall notification?
• 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.
• Some products affected by this recall notification include: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, SystemOne (Q-Series), DreamStation, DreamStation Go, REMstar SE Auto.
Philips Respironics encourages patients and caregivers to look up their device using the serial number and begin the claim process if the device is affected.
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.
For immediate needs, please contact Philips through the direct customer line: 877-907-7508.
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Philips Respironics announced a Voluntary Medical Device Recall Notification for Continuous and Non-Continuous Ventilators (certain CPAP, Bilevel PAPand Ventilator Devices) due to 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.
Philips Respironics encourages patients and caregivers to look up their device using the serial number and begin the claim process if affected.