Datex-Ohmeda S/5 Aespire Anesthesia System 7100
- Company
- Datex Ohmeda, Inc
- Recall Initiated
- September 27, 2005
- Posted
- October 12, 2005
- Terminated
- April 1, 2007
- Recall Number
- Z-0037-06
- Quantity
- 367
- Firm Location
- Madison, WI
Reason for Recall
Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. Also the O2 switch may leak or fail.
Distribution
CA, CO, FL, GA, IL, IN, MI, MS, NM, OK, PA, PR, SD, UT & WA. OUS to: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Canada, Caribbean, Czech Republic, Chile, China, Colombia, Dominican Republic, Ecuador, Finland, France, Germany, Ghana, Great Britain, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Oman, Palestine, Peru, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Arab Emerites, Venezuela & Vietnam.
Lot / Code Info
AMXJ00203, AMXJ00204, AMXJ00248 thru AMXJ00257, AMXJ00259, AMXJ00260, AMXJ00262 thru AMXJ00305, AMXJ00308 thru AMXJ00312, AMXJ00317, AMXJ00318, AMXJ00333 thru AMXJ00335, AMXJ00338 thru AMXJ00342, AMXJ00350 thru AMXJ00354, AMXJ00380 thru AMXJ00411, AMXJ00416, AMXJ00419 thru AMXJ00425, AMXJ00429 thru AMXJ00442, AMXJ00451 thru AMXJ00473, AMXJ00485 thru AMXJ00576, ZMXJ00581 thru AMXJ00629, AMXJ00631 thru AMXJ00639, AMXJ00641 thru AMXJ00699
Root Cause
Other
Action Taken
Urgent Medical Device Correction letter dated 09/23/05 was sent to all customers. The letter describes the issues, affected device serial numbers and recommends that customers DO NOT USE the internal auxiliary oxygen flowmeter, if installed in their system, and to use alternate auxiliary oxygen sources, i.e. wall-mounted oxygen flow meter, in the interim. A GE service representative will contact the customers to schedule an upgrade, performed at no charge.