Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part… recallZ-0969-04 · Datex-Ohmeda Inc · initiated Apr 16, 2004
Terminated All recalls posted in July 2004
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
Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
FDA root cause category: Other
What the company is doing
Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.
Recall details
- Recall number
- Z-0969-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 16, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Datex-Ohmeda Inc
- Quantity
- 10 units
- Product code
- CBN
- FDA submissions
- K993410
- Distribution
- The affected units were distributed nationwide in the United States and worldwide.
Product description
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.
Code information (models, lots, serial numbers)
Serial numbers AMTG00208, AMTG00212, AMTG00213, AMTG00216, AMTG00219, AMTG00220, AMTG00222, AMTH00113, AMTH00121, and AMTH00124
Other devices under the same FDA submission
1 device cleared under K993410 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Aestiva MRIDatex-Ohmeda Inc · Gas-machine, anesthesia157 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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