Spacelabs Healthcare, Inc. recalls Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult…

Recall date

August 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2261-2020

FDA classification

Class II

Brand / firm

Spacelabs Healthcare, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.