The FDA has identified another recall for Royal Philips‘ (NYSE:PHG) Respironics business, confirming it as Class I, the most serious kind.
Philips said last summer that it is no longer taking orders of sleep therapy systems as it handles an earlier recall, which may knock it out of the sleep therapy market for a year. last year’s urgent medical device recall for Philips’ DreamStation continuous positive airway pressure (CPAP) devices.
The FDA classified the company’s recall of the DreamStation continuous positive airway pressure (CPAP) devices as Class I, the most serious kind, in July 2021 as a result of polyester-based polyurethane (PE-PUR) sound abatement foam breaking down, allowing for the potential for the foam to enter a device’s air pathway, causing a host of health problems and toxic carcinogenic effects for the user.
Along with supply chain issues, the Respironics recall adversely affected Philips’ fourth-quarter earnings, which it confirmed earlier this week.
The latest recall — initiated by Philips on Dec. 21, 2021 — covers Philips’ Trilogy Evo ventilator and the repair kits for the Trilogy Evo’s muffler assembly. Affected devices were manufactured and distributed between April 15, 2021, and May 24, 2021. To date, 215 ventilators and 51 repair kits have been recalled in the U.S.
FDA said in a notice that the reason for the recall again centers around the PE-PUR foam, with lab testing of the Trilogy Evo identifying the issue. Ventilators with non-conforming foam were distributed to customers in the U.S. and Korea, but the company has reported no injuries or death to date.
Philips’ Trilogy Evo is suitable for continuous or intermittent positive airway pressure ventilation for pediatric through adult patients in institutional, home and non-emergency transport settings. It may be used for invasive and non-invasive ventilation.
Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same risk. Certain other Trilogy models — Evo O2, EV300 and Evo Universal — are not affected by the issue and are not included in the recall.