Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling 15 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 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death due to the loss of critical safety alarms.
Plain-English summary
Philips Respironics, Inc. is recalling 15 units of the Trilogy EVO Ventilator (Model Number: GB2110X15B) 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.
The defect causes the ventilator's power alarms to become inoperative, resulting in a loss of all power alarms. This failure causes the device to produce incorrect or unexpected results, failing specific requirements (TSRS1298 and PRD439). The ventilator is intended for pediatric through adult patients weighing at least 2.5 kg.
The recall is classified as Class I by the FDA. The 15 affected units were distributed to countries including Great Britain, Germany, Denmark, Italy, France, Ireland, Kuwait, Qatar, Poland, Spain, Austria, Philippines, United Arab Emirates, Slovenia, and Czechia. No units were distributed in the United States. Specific serial numbers for the affected units are listed in the official recall record.
The recalled product
- Product
- Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B 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
- 15
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 (15)
- Model/Material Number: GB2110X15B Serial Numbers: H24736983B2CC
- H247625953F39
- H24999941FF8D
- H251261507A86
- H251283213DFD
- H251283452F09
- H25128825527F
- H25128931575F
- H251291825B15
- H25129198ED97
- H255930567C7B
- H256003738FD6
- H25621580E26F
- H256243863FD7
- H25630201A6DC
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 EV300 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 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo Universal obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy EV300 ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- SevereTrilogy Evo Ventilator Recall Due to Potential Loss of Ventilation
FDA (Devices) · 2024-04-24
- SeverePhilips Trilogy Evo Ventilator Recall: Potential Loss of Ventilation Due to False Alarm
FDA (Devices) · 2024-04-24
- SevereTrilogy Evo O2 Ventilator Recalled for Potential Sudden Loss of Ventilation
FDA (Devices) · 2024-04-24
- HighTrilogy Evo Ventilator Software Defect May Cause Pressure Increase
FDA (Devices) · 2021-08-25
- SeverePhilips Respironics Trilogy Evo Ventilator Software Update Addresses Safety Issues
FDA (Devices) · 2024-09-11
- SeverePhilips Trilogy EV300 Ventilator False Power Alarm Defect Recall
FDA (Devices) · 2024-04-24