Class 1 Device Recall Garbin EVO

• Date Initiated by Firm: March 19, 2024
• Date Posted: April 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1500-2024
• Recall Event ID: 94263
• 510(K)Number: K181166
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
• Code Information: Model No. LD2110X23B, UDI-DI: 606959057432; Serial No. H252356907DD7, H2612106781C2, H261387955F3A, H261571963219, H2619203865AC, H27144085F2DA, H2981485410EF, H29814870657B, H299104069E21, H2991072461E7, H2991911756AE, H29924135D04F, H299272315CC2, H2993291565E3, H2993303190D2, H29936459457C, H299366416554, H31909781664E, H319121138FCC, H31915513BB8C, H3191553299B5, H31944077AA2A, H32107059F10F, H32259997A9A4, H32260005251F, H322744746357, H247407147A36, H25233095B739, H31943269B815, H32106647CBCB, H322783721D50, H32305876CDAA, H32338749C3B1, H32338792CD1A, H3233886753B8, H32338887C9A8, H323389735698, H32339112C9B8, H32339122E3D0, H32339188B1FA, H323392032E8D, H32340206B09F, H32340265D6D4, H32340266E44F, H3234028986A8, H3234033938DC, H3234047519D5, H323405754309, H3234066796A7, H32340689E5C9, H32340720DFA4, H3234078022D4, H323407857579, H323408860D25, H3234091680E1, H32340920CFBF, H3234092843F7, H32340936B351, H32340937A2D8, H32341039CB03, H323410566724, H32341085E5C7, H3234109827FA, H3234110137FF, H323411563DF8, H32342253A0FC, H32348004C3ED, H32352346BF11, H32352363DB0C, H323524606592, H32352655ADEF, H32352731E5C7, H323528496E40, H32352851FBD0, H323528827933, H3235288368BA, H323529194A24, H3235292698BB, H32354143169E, H323541446221, H323541667283, H323541698A74, H32354185DA08, H32359489A256, H32359514F477, H32359586007D, H3235960402CB, H32359609D92E, H32359618D17F, H32359628FB17, H323596306E87, H32359648AFC7, H323596556DFA, H323596565F61, H323596667509, H323596755E4A, H32361320B6F6, H323613569EC8, H32361365863B, H323613815A0F, H3236139360C5, H3236149589F6, H323651234339, H323651689A8A, H323733494DD5, H32373468E3E9, H323735125B67, H323735236086, H323735362EF3, H32373603BC52, H32373604C8ED, H323736080281, H32373612B403, H32373617E3AE, H323736837292, H32373713FF56, H323738794E1B, H323739158A7B, H3237405437AD, H323764137E65, H3237647985EF, H32376487EF59, H323765212DC3, H323765561474, H32376569C6EB, H32376577364D, H32376591C96B, H32376632E9E4, H32376724CFD6, H32376815BEF0, H323768248511, H32381020382A, H32381029A5EB, H3238103467D6, H323810406CFA, H32381049F13B, H3238107400B6, H32384038C3ED, H323937778C1A, H32393793502E, H32393799FF74, H32731689D902, H327393041042, H32739793D084, H327398016E49, H3273981531B5, H3273983055A8, H327398445E84, H32739856644E, H327398883D48, H32739891B951, H327399771CAB, H327399886794, H327400124A77, H327400500E05, H32741331B883, H327413468134, H327413587192, H32741377BAD5, H32741389D063, H3274145071DF, H3274147736D0, H327414884DEF, H327414895C66, H32741518C02B, H327415502B03, H327415745E97, H327416861129, H327417249597, H32741725841E, H32807068EF9D, H32807193885A, H328082175D23, H3280836569E5, H32809514FF06, H32809522B058, H328095934579, H32809599EA23, H328096062AA8, H3280963246E4, H32809638E9BE, H328096457F53, H328096521234, H32809662385C, H328096676FF1, H328096777629, H328096909886, H328265543C17, H32826956BAA6, H3283578725C5, H800011478413, H800011487CE4, H80001158653C, 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H80015223002B, H800156764A5F, H80015678A321, H80015685FB0C, H80015687D81E, H80015858808A, H80015887C805, H800159064D90, H800159165448, H800162473712, H800162572ECA, H80017598EF23, H800176005B17, H800176027805, H8001761042CF, H8001778952CA, H80017790D6D3, H80017792F5C1, H800178004B0C, H358264469B19, H35828734B425, H80001153DBEF, H80001154AF50, H800071279B59, H80007146DE00, H80007147CF89, H80007148377E, H800071539075, H80007156C7D8, H800071876629, H800072157D47, H800072222390, H80007225572F, H8000722665B4, H80007227743D, H800072716FB3, H800072770A85, H80007278F272, H8000731342AD, H800073161500, H800073170489, H80007318FC7E, H80007375734B, H800075679F58, H800075787E77, H8000758071F7, H80007583436C, H80007585265A, H800075935AB4, H8001332646C0, H800133303A2E, H80013345208B, H80013419185A, H80013441EAAA, H80013442D831, H80013567E6F0, H800135719A1E, H80013574CDB3, H80013577FF28, H800135833AC4, H800135844E7B, H800135888417, H80013671757A, H800137070798, H800150807A78, H80015082596A, 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H25235651C5FE, H25235661EF96, H25235714AFEF, H25390190D706, H25390192F414, H253901949122, H2539019580AB, H25390196B230, H258930334AD9, H25904803A41D, H25951953C87A, H2595196496AD, H259519658724, H25951972EA43, H259519927053, H2595199504EC, H259520233CA1, H25952068E512, H259578568E91, H260602753B30, H260652015E4B, H260722100A7F, H2607224074C7, H260796861B25, H260799385C34, H26079974F138, H260801082301, H2608422556DC, H260842606611, H260842707FC9, H260843882A95, H26084443B1E3, H261207405673, H26121060F57D, H261211179616, H26123458094A, H261236234F29, H261236261884, H26124134F96A, H26124141E3CF, H261261943D6C, H261262654049, H26126527883E, H261266121A9F, H261342577B01, H261342838D5D, H26138824E0DC, H261389800154, H261391144A11, H26149439AB25, H2615280525D3, H261567464803, H26156792BE5F, H261568507E2A, H261568740BBE, H261569235B65, H2615719146A6, H261572017EDA, H2616621431D8, H261662340268, H2616628283F6, H26166317599F, H261663540C64, H261920278483, H261920529E26, H26192112A39A, 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• Recalling Firm/ Manufacturer: Philips Respironics, Inc.; 1001 Murry Ridge Ln; Murrysville PA 15668-8517
• For Additional Information Contact: Philips Customer Service; 1-800-345-6443
• Manufacturer Reason for Recall: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
• FDA Determined Cause: Device Design
• Action: Consignees were mailed an URGENT MEDICAL DEVICE CORRECTION notice, dated 3/7/24. Consignees are asked to identify any affected product in their inventory and follow the provided instructions in order to continue using devices safely in CPAP or PSV mode. Devices that alarm are to be immediately plugged into a power source if a Loss of Power Alarm occurs. If no source of power is available, remove and replace the detachable battery. Devices running on software other than 1.05.06.00 can be updated to the latest software version, which does not experience this failure mode. The provided recall notice should be shared with all members of consignee organizations that utilize the recalled devices. If product was further distributed the provided notice should be forwarded. Consignees with any questions can contact Philips Respironics Customer Service at 1-800-345-6443 for homecare customers or 1-800-722-9377 for hospital customers.
• Quantity in Commerce: 1,233 units
• Distribution: Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, US, UY, VN, YT, ZA, ZW.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK