FDA Device recall Z-2077-2014
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09)
- FDA Device
- Class II
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class II recall of Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09) by Spacelabs Healthcare, citing with this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2077-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-18 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spacelabs Healthcare |
| Distribution | GA |
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
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Identifiers
| code_info | Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 25…Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Spacelabs Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2077-2014%22
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