Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at
Check against the official notice below — it lists the full affected range.
Philips is recalling specific Trilogy Evo ventilators due to defective sound abatement foam supplied by one of its manufacturers. A supplier incorrectly used polyester-based polyurethane (PE-PUR) foam instead of the approved material in certain devices and repair kits. This non-conforming foam may degrade into particles that could enter the device's air pathway and be inhaled or ingested by users. The foam degradation risk may be increased by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may release certain chemicals when the device is first used.
A total of 473 affected devices have been distributed across specific U.S. states (Arkansas, Colorado, Florida, Iowa, Illinois, Kentucky, Louisiana, Michigan, Montana, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, West Virginia, and Wyoming) and internationally to Argentina, Brazil, Romania, and the Netherlands. The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
Reason for recall: Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device. Distribution: Worldwide Distribution: Distributed to the following US states: AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands. Quantity: 473 devices Lot/code info: UDI-DI: 00606959051942 (USA); 00606959055483 (Korea) Product Identifier (Serial Numbers): H312385987BBD H31238613E4CA H31241259862E H31241349C52A H312413624849 H31246293D7F5 H29069399D107 H29669926A6D8 H296700951ED2 H296701855DD6 H29674238FF13 H296742474AEC H31220934079E H312209523678 H31220968B34A H280964980B5B H2967018997BA H296723150600 H2967242692F6 H296742253D2E H29674250278B H312207401CA9 H312208968320 H312209071F6D H31220910720A H3122091706B5 H31220928D42A H29670062E9A5 H29670177FD0C H2967017805FB H29672401D5F9 H29672403F6EB H29674270143B H297843621AFA H312413504133 H312209241E46 H312209466984 H2967239902AC H31220819B517 H312208463358 H31220879E1C7 H3122089792A9 H3122092149EB H3122086600E8 H3122093262A8 H31220939DC7B H31220950156A H312209603F02 H31220996D9FC H3122081028D6 H3122083329FD H31220840566E H312208540992 H3122086065DE H31220844104A H312209006BD2 H31220908E79A H3122093041BA H311986468D0A H31198653C37F H31198703E71B H311987378B57 H31199129B193 H311991651C9F H312002723AE6 H3120033750F7 H3120041817B5 H31200649CD3C H3120080642B0 H312008165B68 H312010168111 H3120105192CE H312010580F0F H31201122B781 H31201136E87D H31201153EB00 H31201160F3F3 H31206064B82A H31238478BB71 H31238600CF89 H312386149075 H31238626990F H312413562405 H312413642D7F H312413653CF6 H312413671FE4 H312413707283 H31245188BA57 H31246258C086 H3124630068AA H29670055B772 H29670089CD66 H29670120F70B H29670195440E H296723243DE1 H29672330621D H2967240593DD H29672456DFFE H296742224991 H29784208BBAC H312209272
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.