Recall Z-0021-2007 ยท BSZ Gas-Machine, Anesthesia
Datex - Ohmeda, Inc
GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company
| Date | Nov 7, 2006 (initiated Aug 10, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 471 |
| Distribution | AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061609 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc., Jun 27, 2006 |