Reported Feb 2, 2022 · Ongoing
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or…
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI
00606959051942 (USA)00606959055483 (Korea)
- Product Identifier (Serial Numbers)
507 of 507 codes
H312385987BBDH31238613E4CAH31241259862EH31241349C52AH312413624849H31246293D7F5H29069399D107H29669926A6D8H296700951ED2H296701855DD6H29674238FF13H296742474AECH31220934079EH312209523678H31220968B34AH280964980B5BH2967018997BAH296723150600H2967242692F6H296742253D2EH29674250278BH312207401CA9H312208968320H312209071F6DH31220910720AH3122091706B5H31220928D42AH29670062E9A5H29670177FD0CH2967017805FBH29672401D5F9H29672403F6EBH29674270143BH297843621AFAH312413504133H312209241E46H312209466984H2967239902ACH31220819B517H312208463358H31220879E1C7H3122089792A9H3122092149EBH3122086600E8H3122093262A8H31220939DC7BH31220950156AH312209603F02H31220996D9FCH3122081028D6H3122083329FDH31220840566EH312208540992H3122086065DEH31220844104AH312209006BD2H31220908E79AH3122093041BAH311986468D0AH31198653C37F
- UDI-DI
- Amount recalled
- 473 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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