Philips Respironics, Inc.: Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and T

Hazard

Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

Details from the source

Reason for recall: Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider. Distribution: US Nationwide. Global Distribution. Quantity: 18,855 devices Lot/code info: UDI-DI: 606959052017 606959056497 606959061033 606959052321 606959058613 606959058620 606959058644 606959058668 606959058675 606959058682 606959058705 606959058798; Serial Numbers: H800088856BDC H800088865947 H80008889A1B0 H800088913420 H8000889206BB H800089218A54 H295004989AF7 H295005081733 H29500526CDFD H29500537C5AC H29500543CE80 H29500550E5C3 H29500557917C H29500562ECB9 H2950058276A9 H29500589C87A H295005940A47 H2950064102F6 H29500644555B H2950064767C0 H295006500AA7 H295006566F91 H295006577E18 H295006599766 H29500695F4AA H295007020DD1 H29500710371B H29500716522D H295007210CFA H2950072769CC H295007333630 H29500748C5EB H29500782C311 H29500785B7AE H29500791E852 H29500808E84C H295008107DDC H2950081618EA H295008304E6C H295008362B5A H295008400364 H2950084554C9 H2950086030D4 H2950086213C6 H29500867446B H295008731B97 H29500878A544 H29500881BB4D H29500883985F H29500885FD69 H295109734A0F H295684188A77 H29568454277B H295684894CE6 H2956852613BD H295702706AAA H295702771E15 H29570309E0BF H2957035666F0 H295722010F5D H29571147C7A2 H295733206B03 H29638720E91A H2957187552C6 H29570525CFBA H295714846524 H29571655716D H29572553DEF2 H295726025EA7 H2957263057DD H295721975217 H29572909AAB3 H29572948DC5A H295731629AC9 H29573293E7EC H29572435B5C8 H295733352576 H295749410A01 H295753542BB5 H29575430B544 H295754469D7A H29575462E8EE H29575472F136 H29575718E5D8 H295759024341 H295759576A54 H29576146810A H295772160C6D H29577227378C H29577239C72A H295772522D29 H29577269B992 H295772774934 H2957735631D1 H29

UPC codes

606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606959058668, 606959058675, 606959058682, 606959058705, 606959058798

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.