Philips Respironics, Inc.: Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada D

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 Description/ UDI-DI-- Trilogy Evo, Australia 606959051980; Trilogy Evo, Benelux 606959055520; Trilogy Evo, Brazil 606959055476; Trilogy Evo, Canada 606959052307; Trilogy Evo O2, Germany 606959054103; Trilogy Evo, Germany 606959054110; Trilogy Evo, O2, USA 606959051997; Trilogy Evo, USA 606959051942; Trilogy Evo, USA 606959051942; Trilogy Evo O2, Eastern Europe 606959055698; Trilogy Evo, Eastern Europe 606959055544; Trilogy Evo O2, Iberia 606959054097; Trilogy Evo, Iberia 606959054080; Trilogy Evo, O2, EU 606959055674; Trilogy Evo, O2, EU (Non-BT) 606959055681; Trilogy Evo, EU 606959054981; Trilogy Evo, EU (Non-BT) 606959055537; Trilogy Evo O2, France 606959055643; Trilogy Evo, France 606959055506; Trilogy Evo, O2, INT 606959061019; Trilogy Evo, Great Britain 606959054127; Trilogy Evo O2, India 606959055636; Trilogy Evo, India 606959055490; Trilogy Evo, O2, International 606959054059; Trilogy Evo, O2, International (Non-BT) 606959055575; Trilogy Evo, International 606959051959; Trilogy Evo O2, Italy 606959055438; Trilogy Evo, Italy 606959055421; Trilogy Evo, O2, Japan 606959055582; Trilogy Evo, Japan 606959051973; Trilogy Evo, Korea 606959055483; Trilogy Evo, O2, Latin America 606959055599; Trilogy Evo, Latin America 606959055452; Garbin Evo, Linde 606959057432; Trilogy Evo O2, Nordics 606959055650; Trilogy Evo, Nordics 606959055513; Trilogy Evo, USA-Rental 606959060517; LifeVentEVO2 606959057456; Trilogy Evo, Turkey 606959055551; Trilogy Evo, USA-RECERT 606959060500; Ae

UPC codes

606959051980, 606959055520, 606959055476, 606959052307, 606959054103, 606959054110, 606959051997, 606959051942, 606959055698, 606959055544, 606959054097, 606959054080, 606959055674, 606959055681, 606959054981, 606959055537, 606959055643, 606959055506, 606959061019, 606959054127, 606959055636, 606959055490, 606959054059, 606959055575, 606959051959, 606959055438, 606959055421, 606959055582, 606959051973, 606959055483, 606959055599, 606959055452, 606959057432, 606959055650, 606959055513, 606959060517, 606959057456, 606959055551, 606959060500, 606959062962

Source

Official record: FDA (Device enforcement) ↗

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