Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 21 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Philips Respironics, Inc. is recalling 21 units of the Trilogy EVO Ventilator (Model Number: IN2100X15B) due to a software defect. The affected software versions are 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 to lose all power alarms, resulting in inoperative alarm functions.
The defect causes an incorrect or unexpected result that fails specific requirements (TSRS1298 and PRD439). The recall is classified as Class I by the FDA. The affected units were distributed internationally to countries including CH, DE, DK, IT, FR, IE, GB, KW, QA, PL, ES, AT, PH, AE, SI, and CZ. No units were distributed in the US.
The source text does not specify the actions consumers or healthcare providers should take. Users of these specific serial numbers should contact the manufacturer or their healthcare provider for instructions.
The recalled product
- Product
- Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B 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
- 21
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: IN2100X15B Serial Numbers: H256063834784
- H256063861029
- H25606388F957
- H256063953B6A
- H2560640471FE
- H2560640652EC
- H25606409AA1B
- H25772356E64A
- H25841702B83F
- H257725232A36
- H257726780539
- H257553668D8B
- H2577229704BF
- H257724106819
- H257724646335
- H25772518BE8D
- H2577253775CA
- H2577255055A5
- H258161389AA1
- H258416397658
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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