FDA Device recall Z-0493-2022
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positi…
- FDA Device
- Class I
- ongoing
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class I recall of Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positi… by Philips Respironics, citing 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) so….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0493-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-12-22 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Respironics |
| Distribution | AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, WY |
Product
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 least 2.5 kg.
Reason
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.
Identifiers
| code_info | UDI-DI: 00606959051942 (USA); 00606959055483 (Korea) Product Identifier (Serial Numbers): H312385987BBD H31238613E4CA…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0493-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.