Jul

2014

Cl II Spacelabs Ultraview SL Multigas Module

Company:Spacelabs Healthcare Inc
Date of Enforcement Report: 7/23/2014
Class lI:

PRODUCT

Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. Recall Number Z-2077-2014

REASON
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare Inc., Snoqualmie WA on 6/18/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
8 units

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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Cl II Spacelabs Ultraview SL Multigas Module

Amy Sellers

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