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Lower risk Medical device recall · FDA · Published December 8, 2017

Datex-Ohmeda Inc - Medical Equipment

Datex-Ohmeda Inc is a leading manufacturer of medical equipment, including ventilators, monitors, and patient care systems. Their products are designed to improve patient outcomes and healthcare delivery.

🇺🇸 FDA recall #Z-2266-2018Medical deviceDatex-Ohmeda Inc ›
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Recalling firmDatex-Ohmeda, Inc.3030 Ohmeda Dr · Madison, WI 53718-6704
✎ GovInfoNow plain-language explainer

What happened, in plain English

Datex-Ohmeda Inc is a well-known company in the medical device industry, specializing in critical care equipment such as ventilators, patient monitors, and related systems. They are a trusted provider of medical technology solutions for hospitals and healthcare facilities. Read more at govinfonow.com/recall/72355-datex-ohmeda-inc-medical-equipment.

Source Summary by GovInfoNow · govinfonow.com/recall/72355-datex-ohmeda-inc-medical-equipment · Updated August 31, 2026 · FDA enforcement record: FDA #Z-2266-2018

Cite this page

“Datex-Ohmeda Inc - Medical Equipment.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72355-datex-ohmeda-inc-medical-equipment. Based on FDA recall #Z-2266-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2266-2018%22&limit=1).

Why it’s dangerous

Datex-Ohmeda equipment is designed for critical care applications and is generally safe when used as intended. However, any medical device can pose risks if misused or malfunctioning. This product is not associated with known security vulnerabilities.

Who’s affected

Healthcare facilities, hospitals, medical professionals, and patients using Datex-Ohmeda equipment

How to tell if you have this one

Ensure proper installation, regular maintenance, and adherence to manufacturer guidelines for safe operation of Datex-Ohmeda equipment.

  • Brand
    Datex-Ohmeda Inc
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. 1

    Verify that the equipment is installed and maintained according to the manufacturer's specifications.

  2. 2

    Regularly check for firmware updates and apply them as recommended by the manufacturer.

  3. 3

    Ensure that the equipment is used in a controlled environment with proper training for medical staff.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 16 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: nationwideNYRhode Island: named in the noticeRIMassachusetts: nationwideMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, GA, ID, IL, IN, MS, NC, NJ, NK, NV, OH, OK, RI, TX, and WI., and to the countries of : Albania, Argentina, Australia, Bahrain, Bangladesh, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Georgia, Idaho, Illinois, Indiana, Mississippi, Nevada, New Jersey, North Carolina, Ohio, Oklahoma, Rhode Island, Texas, Wisconsin.

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

1. Firm started the recall: Dec 8, 201712. FDA classified it Class II: Jun 20, 201823. Published in FDA’s Enforcement Report: Jun 27, 201834. FDA terminated the recall: Apr 29, 2021420172021
  1. Firm started the recall
  2. FDA classified it Class II
  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

Is Datex-Ohmeda equipment safe for use?

Yes, Datex-Ohmeda equipment is designed and tested to meet strict medical safety standards. However, proper use and maintenance are essential to ensure safety.

How often should I update the firmware?

Follow the manufacturer's recommended schedule for firmware updates, which may vary depending on the specific equipment model.

What should I do if my Datex-Ohmeda equipment malfunctions?

Contact the manufacturer or a certified service provider immediately for assistance. Do not attempt to repair the equipment yourself.

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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-2266-2018 (December 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2266-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 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