Class I — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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 |
| Product | GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. |
| Quantity | 8 |
| Distribution | Nationwide Distribution - including the states of AL, FL, GA, MO, and VA. |
| Initiated | 2012-04-10 |
| Classified | 2012-06-17 |
| Terminated | 2012-07-09 |
| Recall number | Z-1787-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — GE Healthcare, LLC (Z-1787-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61639/
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