FDAOctober 18, 2016device
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
What to do
FDA enforcement status: Terminated
Brands named
spacelabs healthcarespacelabs
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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