Device Recall Spacelabs Healthcare Ventilator Flexport Interface

  • Modelo / Serial
    Serial Numbers Distributed in the US:  436A000660, 436A000663, 436A000664, 436A000666, 436A000667, 436A000669, 436A004306, 436A004307, 436A004308, 436A004309, 436A004310, 436A006122, 436A006123, 436A006441, 436A006442, 436A006443, 436A006444, 436A006452, 436A006573, 436A006589, 436A006590, 436A006591, 436A006592, 436A006593, 436A006594, 436A006595, 436A006596, 6A006597, 436A006598, 436A006599, 436A006600, 436A006601, 436A00670, 436A006966 436A01020, 436A02086, 436A02087, 436A02088, 436A02234, 436A02246, 436A02247, 436A02281, 436A02282, 436A02283, 436A03237 and 436A03238.   Serial Numbers Distributed Outside the US: 436A003628, 436A003629, 436A003630, 436A003631, 436A003632, 436A003633, 436A003634, 436A003635, 436A003636, 436A003637, 436A003638, 436A003639, 436A003640, 436A003644, 436A003645, 436A003646, 436A003647, 436A004162, 436A004166, 436A004197,  436A004198, 436a005205, 436a005471, 436a005472, 436A005638, 436A005641, 436A005642, 436A006087, 436A006088, 436A006151, 436A006193, 436A006248, 436A006249, 436A006250, 436A006262, 436A006389, 436A006390, 436A006397, 436A006445, 436A006446,  436A006522, 436A006523, 436A006524, 436A006570, 436A006571, 436A006572, 436A006609, 436A006610, 436A006611, 436A006612, 436A006613, 436A006614, 436A006616, 436A006617, 436A006618, 436A006619, 436A006620, 436A006621, 436A006624, 436A006625,  436A006950, 436A006951, 436A01023, 436A01094, 436A01095, 436A01096, 436A01097, 436A01098, 436A01099, 436A01100, 436A01101, 436A01102, 436A01103, 436A01104, 436A01105, 436A01106, 436A01107, 436A01108, 436A01129, 436A01152, 436A01190, 436A01191, 436A01192, 436A01193, 436A01194, 436A01195, 436A01197, 436A01199, 436A01200, 436A01212, 436A01213, 436A01217, 436A01298, 436A02023, 436A02024, 436A02025, 436A02026, 436A02027, 436A02188, 436A02233, 436A02262, 436A02264, 436A02590, 436A02591, 436A02592, 436A03193, 436A03239, and 436A03500.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
  • Descripción del producto
    Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA