FDAAugust 25, 2016device
Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
What to do
FDA enforcement status: Terminated
Brands named
spacelabs healthcarespacelabs
Recall history
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