Device 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.
Z-2077-2014
Product summary
- Event
- Event 68611
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units total (3 units in US)
- Official record key
device-enforcement:Z-2077-2014
Official wording
Reason: With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Code information: Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209
Distribution pattern: Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.
Derived failure modes
-
Unknown
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.