Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic
Summary
The FDA issued a Class II for Et Control, Software option for anesthesia gas machine to achieve and maintain t 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-3192-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665
Lot/Code Info: Serial Numbers: 801042711 801031045 801031926 801045423 801011743 801090568 801128677 801011276-1 801011276-10 801011276-11 801011276-12 801011276-13 801011276-14 801011276-15 801011276-2 801011276-3 801011276-4 801011276-5 801011276-6 801011276-7 801011276-8 801011276-9 801078342-1 801078342-10 801078342-11 801078342-12 801078342-13 801078342-14 801078342-15 801078342-16 801078342-17 801078342-18 801078342-19 801078342-2 801078342-20 801078342-21 801078342-22 801078342-23 801078342-24 801078342-25 801078342-26 801078342-27 801078342-28 801078342-29 801078342-3 801078342-30 801078342-4 801078342-5 801078342-6 801078342-7 801078342-8 801078342-9 801102924 801108227 801113705 801114965 801084897 801003006 801004394 801071735 801016238 801050584 801051585 801064585 801013238 801013095 801043259 801088072 801014199 801006762 801052860 801023283 801110573 801064058 801080036 801126195 801064184-1 801064184-2 801059320-1 801059320-2 801091614 801028252 801051344 801030002 800988180 801111226 801028748 801054482 801090144 801083490 801105951 107945491 801101919 801121340 801038810 801053994 801105562 801119480 801049728 801078062-1 801078062-2 801089690-1 801089690-2 801115703-1 801115703-2 801016353 801019099 801041178 801052685 801081089 801126428 800998007-1 800998007-2 801078509-1 801078509-2 801118676-1 801118676-2 801096089 801101334-1 801101334-2 801100493 801039330 801041393 801055432 801119046 801115340 801040296 801111527 801009694 801030435 801061340 801068616 801044691 800992967 801000463 801000846 801013160 801019318 801050351 801058964 801072530 801084650 801123546 801132989 801107094 801073112 801028803-1 801082191 801069983 801117417 801015409 801052571 801015260 801072302-1 801072302-2 801085278 801025248 108226503-1 801051355 801027603 801109512 800997483 801081637 801042760 107906045-1 108053916-1 108053916-2 108224454-1 801086379 801135413 801013416 801028564 801127004 801008246 801012604 801027426 801074100 801088290 310236371 310236376 310240041 310240042 310240043 310242155 310241679 107918076 107919759 310236689 310241141 310241142 310241658 310241953 310234680 310236385 310236881 310237046 310241289 801093641 801034872-1 801034872-2 801034872-3 801048558-1 801048558-2 81544624 81546632-1 81546632-2 81546632-3 81546632-4 81546632-5 81550679-1 81550679-2 81550679-3 81550679-4 81551858-1 81551858-2 81551858-3 801085315 70527837 801059221 70526890 20033613 20034085 20034430-1 20034430-2 20034430-3 70508471 70525803-1 70525803-2 801053404 800992445 801056524 801072691 801036894 801123908 801060720 801003319 801119746 801019081 801085003 801007902 801053051 801061826 801000673-1 801000673-2 801071631-1 801071631-2 801071631-3 801011825 108073330-1 801074634-1 801074634-2 800998014-1 800998014-2 801066810 801027126 801057455 801086239 801109955 801067617-1 801067617-2 801067617-3 801043199 800999253-1 800999253-2 801065015-1 801065015-2 81550411-1 81550411-2 81547645 81548286 81548650 81549748 81546813-1 81546813-2 801105752 81547967 81545881 39047961 107841136 107861401 107941857 107978351 107978475 108105559 81552791-1 81552791-2 801105767 801111863 81553009 81545887 81548567 81550067 81552682-1 81552682-2 81552682-3 108189840 81552497 801014486 801068830 801068831 801044090 801049548 800989605 801007031 801022388 801040963 801094621 801105680 800988523-1 800988523-2 81550139-1 81550139-2 81550139-3 81550139-4 81550139-5 81546491 81552328 801087814 800991563-1 800991563-2 800991563-3 800991563-4 800991563-5 801088958-1 801088958-2 107851114 108186429 81552638 81546199 81549183-1 81549183-2 81549183-3 801131977 801000718 320035726 81552996-1 81552996-2 81551978 81544458 81546083 81552327 801106164 801064461 801112471 801118143 801005425-1 801005425-2 801005425-3 801049573 81552775 81545621-1 81545621-2 801085518-1 801085518-2 801085518-3 801085518-4 801085518-5 81548295 81549346 81546934-1 81546934-2 81546934-3 81546934-4 81546934-5 81548096-1 81548096-2 81548096-3 81549668-1 81549668-10 81549668-2 81549668-3 81549668-4 81549668-5 81549668-6 81549668-7 81549668-8 81549668-9 81550123-1 81550123-2 81550123-3 81550123-4 81550123-5 323010347 801095588-1 801095588-2 800989609 801014580 801027881 801050682 801050687-1 801050687-2 801083571-1 801083571-2 801105662-1 801105662-2 99019578 107906890 81550828 81551765 99019574 800991680 801080524 800997072 800998893 801050798 801081436 108207332 801009250 801041678 801079409
Quantity Affected: 410 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-3192-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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