The Continuous and Non-Continuous Ventilators are used to provide invasive and non-invasive support for people needing respiratory support or treatment for sleep disorders. Manufacturing Dates: Apto April 22, 2021.Noncontinuous Ventilators: SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, and REMstar SE Auto).
Continuous Ventilator, Non-life Supporting devices: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+, and.Continuous Ventilator, Minimum Ventilatory Support, Facility Use: Philips Respironics E30 with Humidifier.The recall described in this notice is the same one that was announced in the FDA Safety Communication on June 30, 2021. Use of these devices may cause serious injuries or death. As soon as we have the information and resources to do so, we will be helping our patients navigate this process in any way possible.įor additional information and customer support, and to register your unit, please refer to the Philips website, or call their toll-free number: 1-87.The FDA has identified this as a Class I recall, the most serious type of recall. Please know that the health and safety of our patients is of the utmost importance to us, and we are working closely with Philips Respironics to gather more information about repair or replacement options for affected units as it becomes available. Once registered, you will be receiving information regarding how to proceed with the next steps, directly from Philips Respironics. The notice includes information about the recall and what you, the user, should do at this time, including taking the important step of registering your machine on the website. As a Dreamstation CPAP or BiPAP user, or a Trilogy user, your prescribed device is included in this recall. “Urgent: Medical Device Recall Notice” from Philips Respironics, released on June 14, 2021.
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