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.
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: 21,520 devices Lot/code info: UDI-DI: 606959051997 606959054059 606959055575 606959061019 606959055599 606959055636 606959062085 606959055643 606959055650 606959055438 606959054097 606959054103 606959055674 606959055681 606959055698 606959057456; Serial Numbers: H236054270DD5 H23630215A1ED H23630353F967 H23708996882F H24371560D579 H24762460B180 H24762461A009 H24762464F7A4 H255384963A07 H255386624A53 H25781923C0A4 H2578201604B2 H257820401F3C H257820445918 H25782086D3AA H25782201DC6D H25787261E6EA H2578730964AE H25787344D82B H2578742046DA H257930337750 H257930373174 H25793039D80A H25793041194A H257930433A58 H257930444EE7 H257930477C7C H25793048848B H25793050111B H257930510092 H257930532380 H2579305546B6 H25793056742D H257930589D53 H257930612AFA H257930621861 H2579306309E8 H257930656CDE H257930665E45 H25793068B73B H257930713322 H2579307201B9 H25793074648F H257930757506 H25793085F6CE H257930929BA9 H25958981A273 H25960485E33C H259605245519 H259838090646 H260429505975 H26079674BBFF H262014691128 H26201588C06D H262017323E27 H262018544506 H26235313105F H262468357A6E H26256287C5EA H26256295FF20 H262563002549 H2625630134C0 H262563289AB1 H262563404229 H26256353696A H26259915AABF H262602426DB1 H26260403CD81 H26260614155E H26260629E4D3 H2626063060CA H262607067548 H26260819DEA0 H262608513588 H2626088909B8 H262608908DA1 H262609000065 H2626092475F1 H26260948EB4D H262609650318 H2626099580D0 H262610840824 H262610936543 H26261102F90E H26261153963F H262611955AA9 H26264213706C H262642447A6B H26264295DB9A H262643435408 H262949
606959051997, 606959054059, 606959055575, 606959061019, 606959055599, 606959055636, 606959062085, 606959055643, 606959055650, 606959055438, 606959054097, 606959054103, 606959055674, 606959055681, 606959055698, 606959057456
Official record: FDA (Device enforcement) ↗
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