Mar

2016

Cl II Spacelab Healthcare Xhibit Central Station

Company: Spacelab Healthcare, Inc.
Date of Enforcement Report 3/16/2016
Class lI:

PRODUCT

Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number Z-1092-2016

REASON
The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error.

RECALLING FIRM/MANUFACTURER
Spacelab Healthcare, Inc., Snoqualmie, WA on 3/10/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1075

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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Cl II Spacelab Healthcare Xhibit Central Station

Amy Sellers

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