Official recall record
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-07-30
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00195278588128
- Brand on record
- Datex-Ohmeda, Inc.
What the authority reported
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-09-29.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2024-07-12 · US FDA — Medical Devices
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat
Other recalls from this brand
- 2026-07-30 · US FDA — Medical Devices
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 - 2026-07-30 · US FDA — Medical Devices
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and a - 2026-07-30 · US FDA — Medical Devices
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000