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Spacelabs Healthcare Inc recalls Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Recalled June 25, 2014 · FDA recall Z-1824-2014 · Spacelabs Healthcare
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. · FDA Class II
Units
46 units distributed within the US; 108 units distributed outside the US.
Sold at
Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
Description
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.
Product
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Manufacturer(s)
Spacelabs Healthcare Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →