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Safety Report: Philips Respironics Trilogy Evo Ventilators- recalled due to inaccurate flow measurements, USA

1 day ago •source fda.gov

Recall notice

Philips Respironics Trilogy Evo Ventilators- recalled due to inaccurate flow measurements photo #1

United States

Philips Respironics issued a voluntary recall for Trilogy Evo Ventilators regarding the use of in-line nebulizers. The products have been distributed nationwide.

Potential hazards to patients from these conditions may include respiratory discomfort; lung injury from too much air in the lungs or change in pressure (volutrauma/barotrauma); low oxygen saturation; or shortness of breath (dyspnea).

The products recalled are Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators.

Trilogy Evo ventilators that have never been used with in-line nebulizers are not affected by this issue and can continue to be used in accordance with the guidance in the field safety notice.

If you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Philips Respironics, Inc.
Brand name: Philips Respironics
Product recalled: Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators
Reason for the recall: The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy.
FDA Recall date: October 07, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-respironics-issues-additional-usage-instructions-trilogy-evo-ventilators-related-use-line

#medicaldevices #recall #us

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