Datex-Ohmeda Inc Datex-Ohmeda Aespire Carestation. This device is not marketed in the US. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Datex-Ohmeda Aespire Carestation. This device is not marketed in the US.
Brand
Datex-Ohmeda Inc
Lot Codes / Batch Numbers
AMZJ00111 thru AMZJ00146
Products Sold
AMZJ00111 thru AMZJ00146
Datex-Ohmeda Inc is recalling Datex-Ohmeda Aespire Carestation. This device is not marketed in the US. due to Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxy. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, GA, IL, IN, MI, MS, NM, OK, PA, SD, UT, WA, PR
Page updated: Jan 10, 2026