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