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.
FDA Recall Z-2077-2014 · Posted 2014-07-17
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Recalling FirmSpacelabs Healthcare Inc
Recall StatusTerminated
Product CodeCBR
Date Initiated2014-06-18
Date Terminated2014-12-08
Product Quantity8 units total (3 units in US)
Reason for Recall
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Firm Action
Spacelabs sent an Urgent Medical Device Correction letter dated June 20, 20/14 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers are informed that Spacelabs Field Service personnel will be contacting their facility to schedule a convenient time to confirm, at no cost, a software update is needed to resolve this issue. Customers with questions are instructed to contact Spacelabs
Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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