Philips Respironics recalled 113,717 Trilogy Evo home-use ventilators worldwide after finding the Obstruction Alarm may fail to trigger, potentially delaying alerts by up to four breaths. The devices were distributed nationwide in the United States and internationally. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Respironics, Inc. or your healthcare provider for instructions. Notification method: Letter
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Model numbers: All Model No., All UDI, All Serial No. Where sold: Domestic nationwide distribution; Foreign distribution to numerous countries listed in the recall. When sold: Not specified in the recall notice. Price: Not specified.
The Obstruction Alarm on Trilogy Evo devices with software version 1.05.15.00 may not trigger within the required timeframe. In some situations, the alarm may delay alerting caregivers by up to four breaths.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Philips Respironics or your healthcare provider for instructions. 3. Follow the recall instructions provided by the manufacturer. 4. If you need a refund or replacement, follow the recall notice directives from Philips Respironics.
Phone: Unknown. Website: FDA enforcement page for Z-1646-2026 recall. Hours: Unknown.
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