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: 537 devices Lot/code info: UDI: 00606959429154 00606959429208 00606959429147 00606959429185 00606959429710 00606959429611 00606959429475 00606959429260 00606959033986 00606959033993 00606959429444; Serial Numbers: TV212103056 TV213062024 TV214101606 TV210092113 TV211113009 TV212022810 TV212062641 TV214031911 TV214040418 TV214040414 TV21404041D TV214041501 TV21404041C TV214061728 TV21406171F TV21412160E TV215030665 TV215100123 TV21706280E TV217092201 TV217122107 TV217122113 TV219090909 TV21909091B TV210081103 TV210082301 TV210092106 TV210102509 TV211051303 TV211080213 TV211092124 TV212051425 TV212062657 TV213042329 TV213050906 TV21402100B TV21403186A TV214040816 TV214060402 TV214100114 TV214100115 TV214102009 TV214102008 TV21507270A TV215100201 TV21608016D TV21608037C TV21608037B TV217120409 TV219090913 TV212062268 TV213121266 TV220111614 TV220112315 TV212062243 TV214081917 TV210072214 TV210072245 TV211060304 TV211060124 TV211060320 TV211060309 TV211092126 TV212020645 TV213012231 TV213042341 TV213092015 TV213102323 TV21401211B TV21401240B TV214021019 TV21402111E TV21403110F TV214030515 TV21403186E TV214052307 TV214060408 TV214070902 TV214072266 TV214081914 TV21408191E TV214100118 TV214101604 TV215010902 TV215040915 TV215051102 TV215061205 TV215061203 TV21506050A TV215072908 TV215082701 TV215082711 TV215091401 TV215092414 TV215093006 TV215100817 TV215100820 TV21510081E TV21511061D TV216021114 TV216021116 TV216021119 TV216021727 TV216021730 TV216031713 TV21603171B TV216031503 TV21603171C TV216040153 TV216
00606959429154, 00606959429208, 00606959429147, 00606959429185, 00606959429710, 00606959429611, 00606959429475, 00606959429260, 00606959033986, 00606959033993, 00606959429444
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.