FDAAugust 30, 2019device

Xhibit Central, Model No. 96102 - Product Usage: 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 loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

What to do

FDA enforcement status: Terminated

Brands named

spacelabs healthcarespacelabs

UPCs

10841522100345

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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