The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Reason for recall: The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm. Distribution: US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America. Quantity: 20,807 Lot/code info: UDI: 00606959429055 00606959429253 00606959429093 00606959429130 00606959429048 00606959429680 00606959023178 00606959429246 00606959429079 00606959429086 00606959429697 00606959429116 00606959034037 00606959429321 00606959429314 00606959429246 00606959429536 00606959429635 00606959429628 00606959429383 00606959429499 00606959429482 00606959034020 00606959429420 00606959429413; Serial Numbers: TV109102251 TV109102602 TV109111825 TV109111810 TV110030902 TV110042726 TV110051323 TV110062401 TV110062348 TV110102945 TV111042866 TV111061742 TV111062054 TV111061445 TV111062127 TV111062316 TV111121418 TV111121573 TV111121515 TV112022869 TV112051141 TV112051804 TV112070651 TV112091808 TV112092061 TV112092102 TV112092035 TV112111622 TV113061214 TV113042605 TV113043025 TV113050346 TV113052256 TV11311044D TV113082019 TV113091657 TV113110514 TV11310312F TV11311210C TV114011545 TV11401271C TV114110666 TV114022164 TV114022749 TV114022850 TV114030856 TV115021039 TV11403065E TV11405293E TV114061119 TV114062571 TV114063089 TV11408111A TV114082960 TV114090639 TV114100276 TV11410172B TV11503064B TV11504016A TV115042420 TV115032610 TV11505264D TV115032626 TV115032656 TV115061945 TV115072245 TV115081768 TV115091549 TV11510304C TV11604042A TV115072267 TV11709133A TV117030624 TV11708262B TV11712074F TV11801156B TV118030242 TV118030576 TV11803213F TV118050914 TV118051175 TV11805236D TV118053066 TV118082904 TV11809119B TV11809274A TV11810223F TV118103145 TV118112616 TV11902055A TV119032514 TV119052928
00606959429055, 00606959429253, 00606959429093, 00606959429130, 00606959429048, 00606959429680, 00606959023178, 00606959429246, 00606959429079, 00606959429086, 00606959429697, 00606959429116, 00606959034037, 00606959429321, 00606959429314, 00606959429536, 00606959429635, 00606959429628, 00606959429383, 00606959429499, 00606959429482, 00606959034020, 00606959429420, 00606959429413
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.