Philips Respironics, Inc.: Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B,

Hazard

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.

Details from the source

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. 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, Quantity: 34,146 units Lot/code info: Model Number (UDI-DI Number): DS2200X11B (606959052017); IN2200X15B (606959056497); BL2200X15B (606959058668); BR2200X18B (606959058583); CA2200X12B (606959052321); DE2200X13B (606959058651); GB2200X15B (606959058675); ND2200X15B (606959058620); ES2200X15B (606959058644); FR2200X14B (606959058613); FX2200X15B (606959061033); EU2200X15B (606959058682); IA2200X15B (606959058606); IT2200X21B (606959058637); KR2200X15B (606959058590); TR2200X15B (606959058798); EE2200X15B (606959058705). All Serial Numbers.

UPC codes

606959052017, 606959056497, 606959058668, 606959058583, 606959052321, 606959058651, 606959058675, 606959058620, 606959058644, 606959058613, 606959061033, 606959058682, 606959058606, 606959058637, 606959058590, 606959058798, 606959058705

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.