The Recall Desk
ModerateFDA (Devices)·Z-2077-2014·Announced 2014-07-23

Spacelabs Ultraview SL Multigas Module Recalled for Invalid MAC Display

Spacelabs Healthcare is recalling 8 Ultraview SL Multigas Modules because the software displays an invalid Minimum Alveolar Concentration value.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Spacelabs Healthcare Inc is recalling 8 units of the Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). The device is used to monitor gas concentrations and alert clinical personnel when anesthetic agents, oxygen, carbon dioxide, or nitrous oxide move outside user-defined limits.

The recall is due to a software defect where the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. This error could provide incorrect data to clinical personnel.

The affected units were distributed worldwide, including in the state of Georgia in the United States, as well as in Malaysia, Paraguay, and France. Affected serial numbers are 2518-000183, 2518-000184, 2518-000185, 2518-000186, 2518-000206, 2518-000207, 2518-000208, and 2518-000209. Users should contact Spacelabs Healthcare for further instructions.

The recalled product

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

Distribution

Distributed in 1 state: