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: 57,395 devices Lot/code info: UDI-DI: 606959051942 606959051959 606959051973 606959051980 606959055452 606959052307 606959055476 606959055483 606959055490 606959062092 606959055506 606959055513 606959055421 606959054080 606959054110 606959055520 606959054127 606959054981 606959055544 606959057432 606959062962; Serial Numbers: H316330493348 H31633062BE2B H31633067E986 H3163306900F8 H316330719568 H31633072A7F3 H31633073B67A H31633074C2C5 H31633077F05E H31633084410D H316330899AE8 H316330910F78 H316330923DE3 H3163309892B9 H31633102B027 H3168304974A4 H31683060DAD5 H31683061CB5C H31683081514C H3168308263D7 H3168308406E1 H31683087347A H31683088CC8D H31683090591D H316830927A0F H316830936B86 H316830941F39 H31683100D4D9 H31683101C550 H31683102F7CB H31696034875A H31696053A735 H31696059086F H316960638D5D H31696067CB79 H316960739485 H31696077D2A1 H3169608206C4 H3169608640E0 H316960921F1C H3169609748B1 H31696101A043 H31696105E667 H31696118245A H31696123B0E1 H317352405480 H317354480E11 H31735507CB5A H31735568677D H317359517577 H31735981C50F H317406346246 H3174065070B2 H317406543696 H317406740526 H31740679DEC3 H31740686A5FC H31740691C89B H31740696BC24 H31740701455F H317964963E72 H318068788452 H31806883B949 H31806884CDF6 H31806885DC7F H31806888079A H318368546042 H3183685571CB H318368564350 H31836858AA2E H31861740040C H3186181302E8 H318619467121 H3186198831FF H31862000CAA4 H31961173CE0D H320015337C89 H320015731BE9 H3204332184FC H32043326F043 H32107976A656 H321079795EA1 H321542678438 H321542687CCF H322097635A07 H32209769F55
606959051942, 606959051959, 606959051973, 606959051980, 606959055452, 606959052307, 606959055476, 606959055483, 606959055490, 606959062092, 606959055506, 606959055513, 606959055421, 606959054080, 606959054110, 606959055520, 606959054127, 606959054981, 606959055544, 606959057432, 606959062962
Official record: FDA (Device enforcement) ↗
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