GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia… recallZ-1787-2012 · GE Healthcare, LLC · initiated Apr 10, 2012
Class I Terminated All recalls posted in June 2012
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 GE Healthcare, LLC 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
GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m
FDA root cause category: Process control
What the company is doing
GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 10, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer or Technical Support at 800-345-2700 for questions regarding this notification.
Recall details
- Recall number
- Z-1787-2012
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Apr 10, 2012
- Posted by the FDA
- Jun 17, 2012
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 8
- Product code
- CBK
- FDA submissions
- K023366
- Distribution
- Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.
Product description
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
Code information (models, lots, serial numbers)
Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969
Other devices under the same FDA submission
1 device cleared under K023366 — 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 7900Datex-Ohmeda Inc · Gas-machine, anesthesia1 report
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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