Philips Respironics Ventilators Recalled for Flow Sensor Debris Accumulation
Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as Severe because the FDA designated it as Class I, the highest category for medical devices, which per the rubric establishes a minimum score of 4. Although no deaths or serious injuries have been reported, the potential for patient harm including hypoxemia in a critical respiratory support device meets the threshold for Severe classification.
Plain-English summary
Philips Respironics, Inc. is recalling Trilogy Evo, Garbin Evo, and Aeris EVO ventilators due to a potential issue with the internal flow sensor. These devices are distributed in the United States and globally.
Environmental debris can accumulate on the internal machine flow sensor, causing a partial blockage. This blockage may interfere with the device's ability to accurately deliver pressure, volume, or airflow to the patient.
If the malfunction is not addressed by the care provider, patients could experience hypoxemia, a dangerous drop in blood oxygen levels. This risk is particularly acute for patients who depend on these ventilators for respiratory support.
Patients and care providers should contact Philips Respironics or their local representative if they have concerns about their device.
The recalled product
- Product
- Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B,
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- environmental-debris
- sensor-malfunction
- hypoxemia
- respiratory-failure
Distribution
Distributed nationwide across the United States.
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