Philips Respironics, Inc.: Trilogy Evo Universal Ventilator, Model No. DS2000X11B

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: UDI-DI: 606959052000 US Serial Numbers H28984740CF4E H28984800E2E9 H3069350132A0 H30753614E0AA H30789237223A H307892401B8D H307892445DA9 H307892476F32 H307892646E19 H307892657F90 H30789268A475 H30789269B5FC H30803946EC1A H308039813105 H308040536950 H308040753FD6 H30804091E3E2 H30804129D1DE H3081539229E2 H3081768676D5 H30817950E95C H3081837986AE H30828473B83D H30828515D307 H30835691344C H308357380E21 H308357448945 H30835753E422 H30835756B38F H30835772C61B H3083577791B6 H308357786941 H30835794393D H30835853AEE5 H3083585901BF H30835863848D H30835900B81A H30882857F80C H308829934D54 H308830388E52 H308830607CA2 H30883068F0EA H3088307532D7 H308830868384 H30883094B94E H30883120411E H30883128CD56 H30883139C507 H308831511D9F H3088315991D7 H308831703FA6 H30883178B3EE H308831883026 H308832009DCA H308862087FD5 H308862179EFA H30886226A51B H30886231C87C H308862418574 H30886253BFBE H308862682B05 H30886334C50D H30886337F796 H308863391EE8 H30886342ED33 H308863448805 H3088634953E0 H30886353E562 H30886363CF0A H30886371F5C0 H308863817608 H308864130E07 H308864377B93 H30886449DFE5 H3088646437B0 H308864735AD7 H30886484ADA0 H308864987E14 H308865070B27 H30886519FB81 H30886529D1E9 H3088656319D3 H30886573000B H3088658383C3 H308866090D3D H30886616EC12 H30886624E568 H30886635ED39 H30886643C507 H308866487BD4 H30886661D5A5 H308866684864 H308866814FB5 H30886689C3FD H3088669401C0 H308867690331 H30886775D085 H308867780B60 H308867791AE9 H308867901D38 H30886830AA8F H30886840E787 H308868486BCF H308868587217 H3088

UPC codes

606959052000

Source

Official record: FDA (Device enforcement) ↗

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