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Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B… recallZ-0290-2025 · Philips Respironics, Inc. · initiated Oct 7, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Respironics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-0290-2025
Status
Open, Classified
Initiated by the company
Oct 7, 2024
Posted by the FDA
Nov 13, 2024
Recalling firm
Philips Respironics, Inc.
Quantity
24,249 units
Product code
CBK
FDA submissions
K181166
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 description

Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. 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.

Code information (models, lots, serial numbers)

Model Number (UDI-DI Number): DE2100X13B (606959054103); DS2100X11B (606959051997); EE2100X15B (606959055698); ES2100X15B (606959054097); EU2100X15B (606959055674); EU2100X19 (606959055681); FP2100X10 (606959062085); FR2100X14B (606959055643); FX2100X15B (606959061019); IA2100X15B (606959055636); IN2100X15B (606959054059); IN2100X19 (606959055575); IT2100X21B (606959055438); JP2100X16B (606959055582); LA2100X15B (606959055599); ND2100X15B (606959055650). All Serial Numbers.

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95486).

Sources and updates

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