Oct

2016

Spacelabs Healthcare Xhibit Central Station Cl II

Company: Spacelabs Helathcare Inc.
Date of Enforcement Report 10/5/2016
Class lI:

PRODUCT

Spacelabs Healthcare Xhibit Central Station, Model 96102. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Recall Number Z-2885-2016

REASON
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.

RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare Inc., Snoqualmie, WA on 9/26/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
798 units total (488 units in the US and 310 units outside US)

DISTRIBUTION
Nationwide and Internationally

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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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Spacelabs Healthcare Xhibit Central Station Cl II

Amy Sellers

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