Philips Respironics, Inc.: Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada

Hazard

Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

Details from the source

Reason for recall: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW. Quantity: 90,910 US; 56,273 ROW Lot/code info: Model / UDI-DI: Trilogy Evo, O2, Benelux EV300 606959058668; Trilogy Evo, O2, Brazil EV300 606959058583; Trilogy Evo, O2, Canada EV300 606959052321; Trilogy Evo, O2, Germany EV300 606959058651; Trilogy Evo, O2, USA EV300 606959052017; Trilogy Evo, O2, USA EV300 606959052017; Trilogy Evo, O2, Eastern Europe EV300 606959058705; Trilogy Evo, O2, Spain EV300 606959058644; Trilogy Evo, O2, EU EV300 606959058682; Trilogy Evo, O2, France EV300 606959058613; Trilogy Evo, O2, INT EV300 606959061033; Trilogy Evo, O2, Great Britain EV300 606959058675; Trilogy Evo, O2, INTL EV300 606959056497; Trilogy Evo, O2, Italy EV300 606959058637; Trilogy Evo, O2, Korea EV300 606959058590; Trilogy Evo, O2, Nordics EV300 606959058620; Trilogy Evo, O2, Turkey EV300 606959058798; US Serial Numbers: H284098132DDA H284098302CF1 H33497881D1CB H33497883F2D9 H33497890D99A H334979140BA2 H358294978811 H35830133F8DF H35830506E67B H35830557894A H358305795384 H35830750484D H29713003B682 H297748223EC0 H28409798170E H28409822163B H284098331E6A H28409838A0B9 H284098417070 H2840984427DD H337553143AE3 H337559067353 H337559303C0D H2968179381A6 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 H28

UPC codes

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

Source

Official record: FDA (Device enforcement) ↗

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