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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Spacelabs Healthcare Inc
Distribution
Distributed in 1 state:
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