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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