On Tuesday, Koninklijke Philips N.V. ( PHG ) issued a correction related to the Software Version used in Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators to resolve safety issues that may affect the device’s ability to support patient breathing.

The FDA announcement states that this recall involves correcting devices and does not involve removing them. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

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In March, Philips Respironics notified customers to update the latest software related to Trilogy Evo continuous ventilator devices due to a possible power malfunction. Due to a software issue, these 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.

The company is asking users to install a software update to fix problems, including false power loss alarms, an inaccurate display of the amount of oxygen delivered to the patient, and oxygen volume measurement inaccuracies. 

Philips is also now requiring the use of filters with the devices to prevent environmental contamination.

There have been nine reported injuries. There has been one reported death. The action affects 90,905 units worldwide.

In August 2023, Philips recalled Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt from the environment in the air path of some devices.

In April, the Dutch medical technology firm reached a $1.1 billion settlement in the U.S. related to the recall of its Respironics ventilators.

Price Action: PHG stock is down 1.11% at $32.10 at the last check on Thursday.

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