Recall – Patient monitor power failure leads to loss of audio

Company: Spacelabs Healthcare, Inc.
Date of Enforcement Report: 6/10/2020
Class II

PRODUCT

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.

Recall Number: Z-2261-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Spacelabs Healthcare, Inc. on 8/30/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2197 units

DISTRIBUTION

US Nationwide and International

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