Z-0039-06

Datex-Ohmeda Aespire Carestation. This device is not marketed in the US

Name: Z-0039-06 Datex-Ohmeda Aespire Carestation. This device is not marketed in the US
Creator: Datex-Ohmeda Inc
Published: 2005-09-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-09-27 / Terminated

FDA source

Datex-Ohmeda Inc began a recall of Datex-Ohmeda Aespire Carestation. This device is not marketed in the US on 2005-09-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0039-06
Status: Terminated
Initiated: 2005-09-27
Posted: 2005-10-12
Terminated: 2007-04-01
Recalling firm: GE Healthcare
Product: Datex-Ohmeda Aespire Carestation. This device is not marketed in the US.
Product code: BSZ Gas-Machine, Anesthesia
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.
FDA 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 in commerce: 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.
Product codes and lots: AMZJ00111 thru AMZJ00146

Product code BSZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)