FDA today designated a Philips recall of certain sleep and respiratory devices as Class I, its most serious level.
Devices in the recall number in the millions, according to FDA’s database. There have been more than 1,200 complaints and more than 100 injuries involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. The foam has the potential to enter a device’s air pathway, causing a host of health problems and toxic carcinogenic effects for the user.
Analysts have said that the Royal Philips (NYSE:PHG) recall may benefit respiratory care machines competitor ResMed (NYSE:RMD).
Philips Respironics on June 14 sent customers an “Urgent: Medical Device Recall” letter telling them to discontinue use of their machines until Philips can replace the PE-PUR foam sound abatement component with the new silicone foam sound abatement component.
Devices involved in the recall include:
- Continuous non-life-supporting ventilator devices including the DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+;
- In-facility continuous ventilator devices including the Philips Respironics E30 with humidifier;
- Noncontinuous ventilators including the SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, and REMstar SE Auto).
The manufacturing dates are April 11, 2007–April 22, 2021, and the distribution dates are July 21, 2009–April 22, 2021. Additional information is available on FDA’s website.
