Spacelabs Healthcare Ultraview SL Multigas Module — Class II medical device recall Z-2077-2014
Terminated recall by Spacelabs Healthcare Inc, reported 2014-07-23, distributed in GA. With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1)
| Recall number | Z-2077-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2014-06-18 |
| Classified | 2014-07-17 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2014-12-08 |
| Distributed | GA |
| Countries outside the US | FR, MY, PY |
| Reason classes | software |
| Serial numbers | 2518-000183, 2518-000184, 2518-000185, 2518-000186, 2518-000206, 2518-000207, 2518-000208, 2518-000209 |
| Model numbers | 92518 |
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.
Reason for recall
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2077-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.