FDA-Device2014-07-23Class II
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.
Spacelabs Healthcare Inc
Hazard
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Sold states
Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.
Affected count
8 units total (3 units in US)
Manufactured in
35301 SE Center St, N/A, Snoqualmie, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief