Royal Philips N.V. (PHG) has issued an urgent correction for its Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators. The recall stems from a critical software issue that can lead to a malfunction, potentially affecting the device’s ability to support patient breathing.
The U.S. Food and Drug Administration (FDA) has classified this recall as the most serious type, emphasizing the immediate need for correction. They have stated that the recall involves correcting the devices, not removing them from use. However, the FDA has warned that continued use of the affected ventilators without the necessary software update poses a significant risk of serious injury or death.
The problem lies with a software flaw that can trigger a false “Battery Depleted” or “Loss of Power” alarm, even when sufficient power remains. This can result in a sudden loss of ventilation while the device is still sounding an alarm. Philips has advised users to promptly install a software update to address the issue, which also includes fixes for other problems such as inaccurate oxygen delivery readings and measurement inaccuracies.
This latest recall comes after Philips previously issued a recall for the same line of ventilators in August 2023 due to the presence of dust and dirt in the air path of some devices. In April, Philips reached a $1.1 billion settlement in the U.S. related to the earlier recall.
The current recall affects 90,905 units worldwide. There have been nine reported injuries associated with the software issue, and sadly, one reported death.
Philips is also requiring the use of filters with the devices to prevent environmental contamination.
The company is urging all users of Trilogy Evo ventilators to contact Philips immediately for instructions on how to obtain the necessary software update. This update is critical to ensure the safe and proper functioning of the devices and to protect the health and well-being of patients using them.
