Z-3191-2026Class II

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

Name: Z-3191-2026 Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Creator: Datex-Ohmeda, Inc.
Published: 2026-07-30
License: https://open.fda.gov/license/

Datex-Ohmeda, Inc. / initiated 2026-07-30 / Open, Classified

FDA source

Recall record

Recall number: Z-3191-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-30
Posted: 2026-09-16
Recalling firm: Datex-Ohmeda, Inc.
Product: Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: 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: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 7 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3191-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3189-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3190-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3191-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3192-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code BSZ

K172045Class IIAestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2Datex-Ohmeda, Inc. / cleared 2017-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)