Spacelabs Healthcare Inc recalls Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a

Recalled July 23, 2014 · FDA recall Z-2077-2014 · Spacelabs Healthcare

Hazard

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

Units

8 units total (3 units in US)

Sold at

Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.

Description

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

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.

Manufacturer(s)

Spacelabs Healthcare Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →