Spacelabs Healthcare Ventilator Flexport Interface recall
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Why was Spacelabs Healthcare Ventilator Flexport Interface recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
- Recalling firm
- Spacelabs Healthcare Inc
- Quantity
- 46 units distributed within the US; 108 units distributed outside the US.
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
- Recall date
- June 25, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)