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Use caution Medical device recall · FDA · Published June 1, 2022

GE Healthcare Aisys CS2 and Avance CS2 Anesthesia Systems: O2/Air Pressure Reversal Risk

GE Healthcare recalls Aisys CS2 and Avance CS2 anesthesia systems with specific serial numbers due to potential reversal of oxygen and air pressure transducer connections.

🇺🇸 FDA recall #Z-1389-2022Medical deviceGE Healthcare ›
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Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
✎ GovInfoNow plain-language explainer

What happened, in plain English

GE Healthcare is recalling certain Aisys CS2 and Avance CS2 anesthesia systems because the oxygen and air pressure transducers might reverse, which could lead to incorrect oxygen delivery during surgery. This is serious as anesthesia systems are critical medical devices. Read more at govinfonow.com/recall/60564-ge-healthcare-aisys-cs2-and-avance-cs2-anesthesia-systems-o2.

Source Summary by GovInfoNow · govinfonow.com/recall/60564-ge-healthcare-aisys-cs2-and-avance-cs2-anesthesia-systems-o2 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1389-2022

Cite this page

“GE Healthcare Aisys CS2 and Avance CS2 Anesthesia Systems: O2/Air Pressure Reversal Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60564-ge-healthcare-aisys-cs2-and-avance-cs2-anesthesia-systems-o2. Based on FDA recall #Z-1389-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1389-2022%22&limit=1).

Why it’s dangerous

The oxygen and air pressure transducers in these anesthesia systems could reverse their connections, leading to incorrect oxygen delivery to patients during surgery. This might cause inadequate oxygen levels or excessive air, potentially causing serious complications or harm.

Who’s affected

Healthcare providers using the recalled anesthesia systems, particularly those with the specific serial numbers listed in the recall notice. Patients undergoing surgery with these systems are at risk if the pressure reversal occurs.

How to tell if you have this one

Check the serial numbers on the Aisys CS2 system (starting with APWA, APWB, or APWZ) or Avance CS2/Pro system (starting with APKA or APKB). The specific serial number ranges are listed in the recall notice.

  • Brand
    GE Healthcare
  • Product
    GE Healthcare, LLC recalls GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Identify the serial number on your anesthesia system to see if it matches the listed ranges for Aisys CS2 or Avance CS2/Pro systems.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide Distribution. US nationwide, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Jun 1, 202212. FDA classified it Class I: Jul 19, 202223. Published in FDA’s Enforcement Report: Jul 27, 202234. FDA terminated the recall: Oct 21, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using these systems immediately?

No, but you should check your serial numbers to see if they are in the affected range. If affected, follow the action steps to ensure safety.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1389-2022 (June 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1389-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA