Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Summary
The FDA issued a Class II for Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 by Datex-Ohmeda, Inc.. Reason: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 c.
Details
Source
Device Recall
External ID
Z-3190-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Lot/Code Info: UDI-DI: 00195278588128; Serial Numbers: AQDF40422 AQDE40769 AQDE40771 AQDF40287 AQDF40288 AQDF40290 AQDF40291 AQDF40293 AQDF40294 AQDF40295 AQDF40311 AQDF40313 AQDF40314 AQDE40754 AQDE40755 AQDE40756 AQDE40757 AQDE40759 AQDE40762 AQDE40763 AQDF40296 AQDF40300 AQDF40301 AQDF40302 AQDF40303 AQDD40441 AQDF40399 AQDF40400 AQDF40401 AQDF40423 AQDF40424 AQDF40425 AQDE40743 AQDE40744 AQDE40748 AQDE40749 AQDC40064 AQDE40427 AQDC40059 AQDE40736 AQDF40353 AQDF40354 AQDF40355 AQDF40356 AQDF40357 AQDF40358 AQDF40359 AQDF40360 AQDF40361 AQDF40362 AQDF40363 AQDF40364 AQDF40365 AQDF40366 AQDF40367 AQDF40368 AQDF40369 AQDE40780 AQDE40781 AQDE40782 AQDE40783 AQDE40787 AQDE40788 AQDF40325 AQDF40371 AQDF40372 AQDF40373 AQDE40753 AQDF40312 AQDF40382 AQDF40383 AQDF40384 AQDF40385 AQDF40386 AQDF40387 AQDF40308 AQDF40309 AQDF40310 AQDE40765 AQDE40790 AQDE40792 AQDF40398 AQDF40307 AQDE40766 AQDE40767 AQDE40778 AQDE40770 AQDE40774 AQDE40775 AQDE40776 AQDE40777 AQDE40058 AQDD40417 AQDE40799 AQDE40764 AQDE40800 AQDF40283 AQDF40316 AQDF40317 AQDF40318 AQDF40319 AQDF40320 AQDF40321 AQDF40322 AQDF40323 AQDF40324 AQDF40327 AQDF40414 AQDE40739 AQDE40741 AQDE40742 AQDE40779 AQDF40388 AQDF40389 AQDF40390 AQDF40391 AQDE40737 AQDF40350 AQDF40351 AQDF40352 AQDF40374 AQDF40375 AQDF40376 AQDF40377 AQDF40378 AQDF40379 AQDF40380 AQDF40304 AQDF40381 AQDF40415 AQDF40416 AQDF40417 AQDF40418 AQDF40419 AQDF40420 AQDF40421 AQDE40731 AQDE40732 AQDE40735 AQDF40326
Quantity Affected: 140 units
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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-30
Company
Madison, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Datex-Ohmeda, Inc. has 34 FDA actions in our database, including 28 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Datex-Ohmeda, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Datex-Ohmeda, Inc. have FDA actions?
Datex-Ohmeda, Inc. has 34 FDA actions in our database, including 28 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3190-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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