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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 57,395
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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- SevereTrilogy Evo obstruction alarm may take up to four breaths
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- SevereTrilogy EV300 ventilator recalled as Class I over tidal volume
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Same hazard · environmental debris
See all →- CriticalPhilips Trilogy and LifeVent ventilator models recalled for flow sensor debris
FDA (Devices) · 2023-06-14
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