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U.S. Department of Health and Human Services

Class 2 Device Recall Aisys CS2

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 Class 2 Device Recall Aisys CS2see related information
Date Initiated by FirmJuly 30, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3190-2026
Recall Event ID 99649
510(K)NumberK172045 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductAisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Code Information 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
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 Commerce140 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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