Respironics Trilogy Ventilators Recalled for Faulty Power Supply Component
Respironics is recalling 173 Trilogy 100, 200, and 202 ventilators due to a potential faulty component in the power supply.
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: "The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply."
Plain-English summary
Respironics, Inc. is recalling 173 units of the Trilogy 100, 200, and 202 ventilators. These devices provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation in home, institutional, and portable settings. The recall is due to the potential for a faulty component in the power supply.
The affected units were distributed worldwide, including in the United States and various international markets. The specific model and catalog numbers involved are 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.
Users should contact Respironics for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at…
- Manufacturer
- Respironics, Inc.
- Category
- Medical Device — Ventilators
- Hazard
- Affected units
- 173
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 (9)
- Model/Catalog Numbers: 1032800
- 1040004
- 1040007
- 1054096
- 1054260
- CA1032800
- R1040004
- R1054655
- and 1045151.
Distribution
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