Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling three Trilogy EVO Ventilators in Italy 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 recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric. The defect involves the loss of safety alarms on a life-support medical device.
Plain-English summary
Philips Respironics, Inc. is recalling three units of the Trilogy EVO Ventilator (Model Number: IT2100X21B) in Italy. The affected devices are intended for pediatric through adult patients weighing at least 2.5 kg and are equipped with specific serial numbers: H24371481043C, H243714900C6D, and H24371504C78D.
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 ventilator's power alarms to become inoperative, resulting in a loss of all power alarms. The issue causes an incorrect or unexpected result that fails requirements TSRS1298 and PRD439.
The recall is classified as Class I by the U.S. Food and Drug Administration. The source text does not specify the actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B 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…
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 3
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)
- Model/Material Number: IT2100X21B Serial Numbers: H24371481043C
- H243714900C6D
- H24371504C78D
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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