The FDA said today that a Philips
(NYSE: PHG)
recall of Trilogy Evo continuous ventilators is Class I, its most serious level of recall.
Philips voluntarily initiated the recall in March; the company said that the FDA has had it under a Class I designation since April 17.
According to the FDA, the recall involves 90,905 Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators distributed in the U.S. from March 20, 2019 to Feb. 16, 2024. The ventilators need a software update (version 1.05.06.00) from the company in order to prevent potential power malfunctions. The FDA said that without the software update, the ventilators can issue a “battery depleted” or “loss of power” alarm while sufficient power is still available, resulting in a sudden loss of ventilation while the device alarms.
In a statement provided to MassDevice, the company said: “Philips Respironics is addressing this issue through a software update that is already available to customers in the US. Customers should update all impacted devices to this most recent version of software.”
The company added: “This issue only occurs when the device is operating on firmware other than 1.05.06.00, is in CPAP (continuous positive airway pressure) or PSV (pressure support ventilation) mode, and is not able to detect the respiratory effort of the patient for at least 10 minutes and 55 seconds. If operating the device in other modes, no additional mitigations are required.”
The FDA said there are no reports of death or serious injury related to the recall. The agency has more information available on its website.
The recall comes about a year after another Class I recall involving Trilogy Evo ventilators that involved potential dirt from the environment getting into the air path of some devices.
In addition, Philips continues to work to resolve a three-year-old recall involving 5.5 million CPAPs and other respiratory devices that had sound abatement foam that could potentially degrade and get into device airways. Last month, the Dutch medtech giant finalized a consent decree with the FDA and U.S. Justice Department that governs its handling of the recall. The same month, it also announced a $1.1 billion settlement of personal injury claims filed in the U.S. In addition, a federal judge approved a settlement of $613 million over economic losses related to the recall.
MassDevice has a full timeline of the Philips Respironics recall.
