FDAFDA · Food and drugs·Recall number Z-1651-2023
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Published June 14, 2023 · Recall initiated: May 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Respironics, Inc.
- Distributor
- US Nationwide. Global Distribution.
- Lot
- 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 H2957737176DE H29577382C78D H29638222F3B5 H296384752F6B H296385152167 H29638556749C H296385674F7D H29638579BFDB H29638661C52F H296386649282 H296386694967 H29638673FFE5 H296386804EB6 H29638692747C H29638700DAAA H29638711D2FB H295727388149 H29638731E14B H296387429ED8 H29638754E236 H296387619FF3 H296387790A63 H29638786715C H29638860C4BD H29638870DD65 H29638877A9DA H2963889375EE H29638924BF25 H29638946C8E7 H2963896903A0 H2963898770CE H296389901DA9 H296412616FF1 H296412634CE3 H2964127067A0 H296412760296 H29641293CF2B H29641294BB94 H2964130527D9 H296413153E01 H29641318E5E4 H29641361352D H2964136207B6 H29641367501B H296413703D7C H296413730FE7 H296413756AD1 H32622632A9DB H32622850CE02 H3262287871FA H32622908662E H326229384C46 H32622966DB80 H32622999A0BF H326230373414 H326230630C88 H32623094FBFF H3262312003AF H32623155190A H32623193D59C H326232369025 H32623306E091 H32642646996F H32724874F427 H327248902813 H327248946E37 H32724904E3F3 H32913305F24F H3292422197EA H32977138FF0E H32977139EE87 H33004363256A H295650490DA8 H295712761327 H29571445DD0D H295719948383 H295773969871 H296385060A24 H296412661B4E H29641282C77A H2964128790D7 H352431781D73 H352431832068 H352442532855 H352442674419 H352442731BE5 H35244286CF80 H352442893777 H35244297C7D1 H352443671EC5 H352443743586 H35244378FFEA H35244384B64E H35244385A7C7 H3526121552DC H35261229B2D8 H352612714028 H35261279CC60 H352612959C1C H35261318D3E5 H35261328F98D H352613464423 H3526136231B7 H352613698F64 H27736231F4BE H277362379188 H27736246CD09 H277372867812 H27737288916C H2773729661CA H27737302AA2A H27737306EC0E H2773730914F9 H27737331B2D9 H27737344A87C H277373468B6E H277373596A41 H277373815671 H2773738401DC H2773740998FC H277374132E7E H277374212704 H277374525897 H277374740E11 H277374848DD9 H27737492F137 H27737496B713 H277375206C51 H277375242A75 H2773757677DF H277375789EA1 H27737583A3BA H27737593BA62 H27737607C43A H27737614EF79 H27737624C511 H27737635CD40 H27737646B2D3 H27737656AB0B H27737664A271 H2773767871C5 H277376870AFA H27737700EA59 H27737702C94B H277378459053 H27737846A2C8 H27737847B341 H27737853ECBD H277378549802 H27737869698F H277378779929 H277378925494 H277378970339 H2773792845BA H27737966CBA4 H27737971A6C3 H277379821790 H2773801950BC H27738021F69C H277380378A72 H27738043815E H27738052890F H27738057DEA2 H277380680C3D H277380801A65 H277380867F53 H27738088962D H277380933126 H277381019FF0 H2773814974D8 H27738152D3D3 H27738154B6E5 H277381587C89 H27738160DAA9 H27738171D2F8 H27738176A647 H27738177B7CE H27738188CCF1 H277381963
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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