Difference between revisions of "Philips Respironics Recall 2021"

Revision as of 22:26, 14 July 2021

Timeline

April 26, 2021

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update 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.

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.

June 14, 2021

https://www.apneaboard.com/PR-Recall.pdf 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.

Impacted Devices

All Devices manufactured before 26 April 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

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