GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-O
FDA device recall Z-0021-2007 · posted 2006-11-07 · Terminated
Recall details
- Recalling firm
- Datex - Ohmeda, Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 471
- Distribution
- AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI,
- Date initiated
- 2006-08-10
- Date posted
- 2006-11-07
- Date terminated
- 2008-02-24
- Location
- Madison, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DATEX-OHMEDA AISYS (K061609) | Datex-Ohmeda, Inc. | 2006-06-27 |