Recall Z-0021-2007
Datex - Ohmeda, Inc · initiated August 10, 2006
Product
GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company
Codes / lots: Serial numbers: ANAK00115, ANAH00114, ANAH00115, ANAH00116, ANAH00117, ANAH00124, ANAH00126, ANAJ00100, ANAJ00101, ANAJ00102, ANAJ00103, ANAJ00104, ANAJ00105, ANAJ00106, ANAJ00107, ANAJ00108, ANAJ00109, ANAJ00110, ANAJ00111, ANAJ00112, ANAJ00113, ANAJ00114, ANAJ00115, ANAJ00116, ANAJ00117, ANAJ00118, ANAJ00119, ANAJ00120, ANAJ00121, ANAJ00122, ANAJ00123, ANAJ00124, ANAJ00125, ANAJ00126, ANAJ00127, ANAJ00128, ANAJ00129, ANAJ00131, ANAJ00132, ANAJ00133, ANAJ00134, ANAJ00135, ANAJ00136, ANAJ00137, ANAJ00138, ANAJ00139, ANAJ00140, ANAJ00141, ANAJ00142, ANAJ00143, ANAJ00144, ANAJ00145, ANAJ00146, ANAJ00147, ANAJ00148, ANAJ00149, ANAJ00150, ANAJ00151, ANAJ00152, ANAJ00153, ANAJ00154, ANAJ00155, ANAJ00156, ANAJ00157, ANAJ00158, ANAJ00159, ANAJ00160, ANAJ00161, ANAJ00162, ANAJ00163, ANAJ00164, ANAJ00165, ANAJ00166, ANAJ00167, ANAJ00168, ANAJ00169, ANAJ00170, ANAJ00171, ANAJ00172, ANAJ00173, ANAJ00174, ANAJ00175, ANAJ00176, ANAJ00177, ANAJ00178, ANAJ00179, ANAJ00180, ANAJ00181, ANAJ00182, ANAJ00183, ANAJ00184, ANAJ00185, ANAJ00186, ANAJ00187, ANAJ00188, ANAJ00189, ANAJ00190, ANAJ00191, ANAJ00192, ANAJ00193, ANAJ00194, ANAJ00195, ANAJ00195, ANAJ00196, ANAJ00197, ANAJ00198, ANAJ00199…
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0021-2007
- Initiated
- August 10, 2006
- Posted by FDA
- November 7, 2006
- Terminated
- February 24, 2008
- Product code
- BSZ – Gas-Machine, Anesthesia
- Quantity
- 471
- Distribution
- AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI,
- Recalling firm
- Datex - Ohmeda, Inc, Madison, WI