Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling eight Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
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: "Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected…"
Plain-English summary
Philips Respironics, Inc. is recalling eight units of the Trilogy EVO Ventilator, Model Number ES2110X15B. The affected devices are intended for pediatric through adult patients weighing at least 2.5 kg. The recall involves specific serial numbers and software versions 1.00.05, 1.01.09.00, 1.01.10.00, and 1.01.11.00.
The recall is due to a software defect that causes inoperative and loss of all power alarms. This defect results in an incorrect or unexpected result that fails specific requirements (TSRS1298 and PRD439). The loss of power alarms could prevent the device from alerting users to critical power issues.
The affected units were distributed to customers in various countries outside the United States, including Germany, France, Italy, and the United Kingdom. No units were distributed in the US. Healthcare providers and consumers should check their device serial numbers and software versions against the recall list. If a device is affected, users should contact Philips Respironics for instructions on how to proceed.
The recalled product
- Product
- Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate…
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 8
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 (7)
- Model/Material Number: ES2110X15B Serial Numbers: H25123324AA45
- H2512383941DE
- H251239768495
- H25124050192C
- H251250171648
- H25125051141E
- H2512510467D7
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 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 13 products in this recall →Related recalls
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