Datex-Ohmeda S/5 Aespire Anesthesia System 7900 recallZ-0038-06 · Datex-Ohmeda Inc · initiated Sep 27, 2005
Terminated All recalls posted in October 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Datex-Ohmeda Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0038-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 27, 2005
- Posted by the FDA
- Oct 12, 2005
- Recalling firm
- Datex-Ohmeda Inc
- Quantity
- 16
- Product code
- BSZ
- FDA submissions
- K050626
- 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 description
Datex-Ohmeda S/5 Aespire Anesthesia System 7900
Code information (models, lots, serial numbers)
ANCJ00100 thru ANCJ00113, ANCJ00116, ANCJ00118
Other devices under the same FDA submission
1 device cleared under K050626 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Aespire 7900Datex-Ohmeda Inc · Gas-machine, anesthesia3 recalls48 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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