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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 app
- 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
Same manufacturer · Philips Respironics, Inc.
See all →- SevereTrilogy Evo Universal obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy EV300 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo O2 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25