Phillips Respironics Recalls Trilogy Ventilators Due to Power Board Defect
Phillips Respironics is recalling 572 Trilogy ventilators worldwide because a defective power management board component may cause loss of therapy.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients."
Plain-English summary
Phillips Respironics, Inc. is recalling 572 units of the Trilogy 100, 200, and 202 ventilators. These devices provide continuous or intermittent ventilator support for pediatric and adult patients weighing at least 5 kg (11 lbs) in home, hospital, and portable settings.
The recall was initiated after internal testing revealed a potentially defective component on the power management board. This defect could affect the function of the ventilators, resulting in a loss of therapy for patients. The affected units were distributed nationwide in the United States and in France, Great Britain, China, India, Italy, Korea, Kuwait, the Netherlands, and Singapore.
Healthcare facilities and consumers should identify affected units by checking the model, catalogue, or code numbers (including 1040000, 1040005, 1054096, 1054260, 1040004, and 1058180) and the specific serial numbers listed in the official recall notice. Users should contact Phillips Respironics for instructions on how to proceed with the recall.
The recalled product
- Product
- Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The…
- Manufacturer
- Phillips Respironics, Inc.
- Category
- Medical Device — Ventilators
- Affected units
- 572
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 (20)
- Model (s)
- Catelogue
- or Code Numbers were identified as: 1040000 Trilogy 202 International
- Number 1040005 Trilogy200 USA
- 1054096 Trilogy 100 International
- 1054260 Trilogy 100 USA
- 1040004 Trilogy 02
- and 1058180 Garbin. Multiple serial numbers also indicated: TV114011447
- TV114011448
- TV114011449 TV11401144A
- TV11401144B
- TV11401144C
- TV11401144D
- TV11401144E
- TV114011450
- TV114011451
- TV11401145B
- TV11401145C
- TV11401145D
- TV11401145F
Distribution
Distributed nationwide across the United States.
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