GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company
FDA Recall Z-0021-2007 · Posted 2006-11-07
Recalling FirmDatex - Ohmeda, Inc
Recall StatusTerminated
Product CodeBSZ
Date Initiated2006-08-10
Date Terminated2008-02-24
Product Quantity471
Reason for Recall
Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alrm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected.
Firm Action
Firm mailed recall letters on August 10, 2006, to consignees telling them what to do if a failure occurred during system checkout or during use, as a short term solution. Later, GE representatives will make visits to each site for modification of the interface valve on each device, as the long term solution.
Root Cause
Other
Distribution Pattern
AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI,
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.