FDAFDA · Food and drugs·Recall number Z-1824-2014
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Published June 25, 2014 · Recall initiated: May 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spacelabs Healthcare Inc
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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