Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 105 Trilogy EVO ventilators because a software defect causes inoperative power alarms. The units are distributed internationally but not in the US.
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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. The defect involves the loss of critical safety alarms in a life-support medical device.
Plain-English summary
Philips Respironics, Inc. is recalling 105 units of the Garbin EVO Ventilator (Linde Model Number LD2110X23B), also known as the Trilogy EVO and Trilogy EVO Universal Ventilator. The recall is due to a software defect in versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00. This defect causes the inoperative status and loss of all power alarms, resulting in incorrect or unexpected results that fail specific requirements (TSRS1298 and PRD439).
The affected devices are intended for pediatric through adult patients weighing at least 2.5 kg. The ventilators can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with appropriate accessories. The recall number is Z-0946-2020.
The distribution pattern indicates that the units were not distributed in the United States. They were distributed in the following countries: CH, DE, DK, IT, FR, IE, GB, KW, QA, PL, ES, AT, PH, AE, SI, and CZ. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- Garbin EVO Ventilator, Linde - Model Number: LD2110X23B 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
- 105
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/Material Number: LD2110X23B Serial Numbers: H239876824C6F
- H239876835DE6
- H23987688E335
- H239876943081
- H23987698FAED
- H239877197F78
- H23987731C080
- H23987734972D
- H240018521FDD
- H24001858B087
- H2400193657F5
- H24739549A36C
- H2473957014C5
- H247401821EC1
- H247406117747
- H247407147A36
- H2474074261B8
- H24746531E009
- H247467227EF2
- H2474675675DE
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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