FDA Medical Device Recalls (openFDA)
Datex-Ohmeda Inc: Datex-Ohmeda Aespire Carestation. This device is not marketed in the US.
- Recall number
- Z-0039-06
- Recalling firm
- Datex-Ohmeda Inc
- Product
- Datex-Ohmeda Aespire Carestation. This device is not marketed in the US.
- Status
- Terminated
- Initiated
- 2005-09-27
- Posted
- 2005-10-12
- Terminated
- 2007-04-01
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 36 This device is not marketed in the US.
- 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, serial or model codes
- AMZJ00111 thru AMZJ00146
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2183066
- Firm city
- Madison
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28