Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified.
FDA Recall Z-2902-2011 · Posted 2011-08-01
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Recalling FirmSpacelabs Healthcare, Llc
Recall StatusTerminated
Product CodeCBR
Date Initiated2011-06-08
Date Terminated2011-09-21
Product Quantity481 units worldwide (333 units internationally and 148 units in the US)
Reason for Recall
Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.
Firm Action
Spacelabs Healthcare, Llc. sent a "Customer Bulletin" dated June 20, 2011 to all affected customers.
The customers were notified of the trend problem and are advised to follow the instructions in the Perioperative section and the ADMIT/DISCHARGE section of the users manual.
For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support or 1-425-657-7200 x5089.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution: (USA) Nationwide distribution, and the countries of ARGENTINA, BAHRAIN, BOLIVIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, ECUADOR, EGYPT, FRANCE, INDIA, MEXICO, NICARAGUA, PARAGUAY, PERU, POLAND, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, CHINA, THAILAND, UNITED ARAB EMIRATES, U.K., URUGUAY, VENEZUELA, and VIETNAM.
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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