FDAFDA · Food and drugs·Recall number Z-2077-2014
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.
Published July 23, 2014 · Recall initiated: June 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spacelabs Healthcare Inc
- Distributor
- Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.
- Lot
- Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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