Trilogy EV300 obstruction alarm may take up to four breaths
Philips Respironics is recalling the Trilogy EV300 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.
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: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Philips Respironics, Inc. is recalling the Philips Respironics Trilogy EV300, software version 1.05.15.00, a continuous home-use ventilator. About 113,717 units were distributed worldwide, covering the United States nationwide and more than eighty other countries.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. The FDA has classified this recall as Class I, its most serious category.
All model numbers, UDIs and serial numbers are affected.
Facilities and users can identify affected devices by the software version above, and may contact Philips Respironics, Inc. for further information.
The recalled product
- Product
- Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 113,717
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All Model No.
- All UDI
- All Serial No.
Distribution
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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