Nov

2016

Model 96102 Cl II Xhibit Central Station

Company: Spacelabs Healthcare Inc
Date of Enforcement Report 11/9/2016
Class lI:

PRODUCT

Xhibit Central Station, Model 96102. 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-0332-2017

REASON
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.

RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare Inc., Snoqualmie, WA on 11/2/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
343 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Model 96102 Cl II Xhibit Central Station

Amy Sellers

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