FDA-Device2020-06-10Class II
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.
Spacelabs Healthcare, Inc.
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.
Sold states
Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.
Affected count
2197 units
Manufactured in
35301 Se Center St, N/A, Snoqualmie, WA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2261-2020Don't want to check this manually?
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