According to the FDA, some Philips Respironics sleep apnea machines are being recalled for a second time.
The FDA has escalated this most recent recall to a Class I recall, which is the most serious kind of recall the organization makes. The recall warns that the defective devices “may fail to deliver any therapy at all. “Only a few versions of Philips Respironics DreamStation1 devices are affected by the recall. To determine whether a system is compromised, users will need to check the serial number on their equipment.
The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021.
Recommendations for People Who Use Recalled Ventilators at Home and Their Caregivers
Do not stop or change ventilator use until you have talked to your health care provider.
Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam’s risks.
If you use one of these recalled devices, follow the recommendations listed below.
Philips recalled the following devices made between 2009 and April 26, 2021:
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- E30
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021, to May 24, 2021, with specific serial numbers.
Source FDA.gov
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