Spacelabs Healthcare Xhibit Telemetry Receiv Cl II

Company:Spacelabs Healthcare
Date of Enforcement Report 2/14/2018
Class lI:

PRODUCT

Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1,
Recall Number Z-0532-2018

REASON
Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.

RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare Inc., Snoqualmie, WA on 1/17/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12 devices

DISTRIBUTION
US Distribution to the states of : VA, NJ, MI, GA, and Internationally to F

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About the author

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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