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Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system… recallZ-3191-2026 · Datex-Ohmeda, Inc. · initiated Jul 30, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/30/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use your Anesthesia system by following the instruction below: 1. Prior to each use, complete preoperative checkout and tests in accordance with the instructions in the User Reference Manual (URM). 2. When Alternate O2 control is enabled, the clinician should adjust the Alternate O2 flow as appropriate for the case. Use the Alternate O2 control knob to adjust the O2 flow. 3. When Alternate O2 control is enabled, flow from the electronic mixer is stopped and the agent concentration is set to off. Two situations are possible regarding the Agent quick key: a. The Agent quick key will be blank on the display if agent delivery is unavailable. Supplement with or transition to intravenous anesthetics as needed. b. The Agent quick key will be present on the display if agent delivery can be resumed. Press the Agent quick key to set the desired concentration and press the key again to confirm. 4. Please evaluate existing service stock for the Field Replaceable Unit (FRU) spare parts listed below and dispose of all affected FRU parts according to your facility procedures. Please ensure all potential staff in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 34147 Digital Response Form or print, fill out manually, scan, and email to [email protected]. Product Correction GE HealthCare will inspect and correct as necessary all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. Contact Information If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recall details

Recall number
Z-3191-2026
Status
Open, Classified
Initiated by the company
Jul 30, 2026
Posted by the FDA
Sep 16, 2026
Recalling firm
Datex-Ohmeda, Inc.
Quantity
7 units
Product code
BSZ
FDA submissions
K172045
Distribution
Worldwide - US Nationwide distribution.

Product description

Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000

Code information (models, lots, serial numbers)

Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443

Other devices under the same FDA submission

6 devices cleared under K172045 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99649).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page