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U.S. Department of Health and Human Services

Class 2 Device Recall Et Control

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 Class 2 Device Recall Et Controlsee related information
Date Initiated by FirmJuly 30, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3192-2026
Recall Event ID 99649
510(K)NumberK172045 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductEt 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
Code Information 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
FEI Number 2112667
Recalling Firm/
Manufacturer		 Datex-Ohmeda, Inc.
3030 Ohmeda Dr
Madison WI 53718-6704
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer 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 Determined
Cause 2		Nonconforming Material/Component
ActionAn 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 recall.34147@gehealthcare.com. 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 Commerce410 units
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSZ
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