Philips Respironics, Inc.: Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X

Hazard

The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.

Details from the source

Reason for recall: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen. Distribution: Worldwide distribution. US Nationwide including Puerto Rico, and countries of AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GE, GT, HK, HR, HU, ID, IL, IE, IN, IT, JP, KW, LB, LT, MM, MQ, MX, MY, NG, NL, NO, NP, NZ, PE, PF, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SI, SK, TH, TR, TW, UA, VN, and ZA. Quantity: 62826 total devices Lot/code info: UDI-DI: 606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606959058668, 606959058675, 606959058682, 606959058705, 606959058798, 606959052000. UDI-DI, Model number: Serial numbers 606959052017, DS2200X11B: H27990931E388, H27990933C09A, H27990934B425, H279909369737, H28068115E37D, H28068117C06F, H28086487E130, H280912810EBA, H28091329255E, H280914614273, H28091549A757, H28091634DEDE, H28091674B9BE, H280918082EC1, H280918779B3E, H28091945C898, H28092332A798, H2809235587F7, H28092419A6FE, H280924344EAB, H280924473138, H28092465219A, H280924717E66, H28092478E3A7, H28092499683E, H2809251427C7, H280925341477, H280925522591, H280925631E70, H28092614C8A3, H28096497F3AC, H280964991AD2, H280965000AD7, H280965011B5E, H2809650229C5, H28096503384C, H280965044CF3, H280965055D7A, H280965066FE1, H280965077E68, H28270803E547, H28270834BB90, H28270854EF40, H28270873A84F, H282708832B87, H28270893325F, H28270902AE12, H28270921AF39, H282709382B20, H282709468F56, H28270960D9D0, H28270971D181, H282710044B81, H282710230C8E, H282710274AAA, H2827103027CD, H2827103642FB, H2827104249D7, H282710516294, H2827105707A2, H28271078CCE5, H28271082E077, H282710895EA4, H282710958D10, H28271104115D, H2827110723C6, H282744145F6F, H282791971106, H2828022698DC, H283571110611, H28357128B1B8, H28357134620C, H283833769D5E, H283833778CD7, H283833787420, H283833807BA0, H283833843D84, H283834175402, H28383418ACF5, H28383419BD7C, H28383432301F, H283834332196, H2838343544A0, H2

UPC codes

606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606959058668, 606959058675, 606959058682, 606959058705, 606959058798, 606959052000

Source

Official record: FDA (Device enforcement) ↗

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