Datex-Ohmeda Aespire Carestation. This device is not marketed in the US.
- Company
- Datex Ohmeda, Inc
- Recall Initiated
- September 27, 2005
- Posted
- October 12, 2005
- Terminated
- April 1, 2007
- Recall Number
- Z-0039-06
- Quantity
- 36 This device is not marketed in the US.
- 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
AMZJ00111 thru AMZJ00146
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.