Z-0292-2025Class I

Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation...

Name: Z-0292-2025 Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation...
Creator: Philips Respironics, Inc.
Published: 2024-10-07
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2024-10-07 / Open, Classified / root cause: design

FDA source

Philips Respironics, Inc. began a recall of Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at... on 2024-10-07. FDA classified it as Class I and gives the reason as "Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0292-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-10-07
Posted: 2024-11-13
Recalling firm: Respironics, Inc.
Product: Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Root cause tag: design
FDA root cause: Device Design
Action: An URGENT Medical Device Correction notification was mailed to consignees on 10/07/2024. The notification provides instructions to users to prevent risks for patients when using in-line nebulizers and a set FiO2. Consignees are to distribute the provided notification to all members of their organization responsible for setting up and supervising patients who use these devices. Additionally, if affected devices were further distributed the notification needs to be provided to them. Philips Respironics is currently investigating the issue and plans to follow-up communications to customers to provide additional guidance and solutions at a later date. Consignees with any questions can contact their local Philips Respironics Customers Service at: For DME and Homecare Customers: 1-800-345-6443, option 4, option 5 For Hospital Customers: 1-800-722-9377, option 2. On 12/27/2024, Philips Respironics sent an updated letter to consignees. It included additional guidance to customers. Dependent upon the scenarios described, customers will be instructed to either contact one of the options provided in the Urgent Medical Device Correction letter for servicing of their device to replace the flow sensor or continue use of the device in accordance with the guidance provided in the Urgent Medical Device Correction letter. Execution of flow sensor replacement will take place through a Field Change Order (FCO). An UPDATED: URGENT FIELD SAFETY NOTICE dated 3/2/26 was mailed to consignees containing recall information for three different failure modes that can be experienced in all Trilogy Evo, Trilogy EVO O2, Trilogy Evo Universal, and Trilogy EV300 devices. The firm identified that using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. This can lead to under-delivery of therapy to the patient. Consignees are being instructed to update all devices with software ve
Quantity in commerce: 9,999 units
Distribution: Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.
Product codes and lots: Model Number DS2000X11B, UDI-DI Number: 606959052000. All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0292-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0290-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13
Z-0291-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13
Z-0292-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13
Z-0293-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13
Z-0294-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13
Z-0295-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13
Z-0296-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13

Product code CBK

K181170Class IITrilogy Evo UniversalRespironics, Inc. / cleared 2019-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)