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Use caution Medical device recall · FDA · Published March 25, 2019

Hamilton G5 Ventilators with Software <= 2.60 Risk of Unassisted Breathing

Hamilton Medical recalls G5 ventilators with software versions 2.60 or older due to potential risk of unassisted breathing. Affected units have serial numbers 16192 and lower.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1874-2019Medical deviceHamilton Medical ›
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Contact the company

Recalling firmHamilton Medical AGVia Crusch 8 · Bonaduz, Switzerland
✎ GovInfoNow plain-language explainer

Hamilton Medical is recalling ventilators with software versions 2.10 or older that could enter an unassisted breathing state, risking patient safety. This could require immediate alternative ventilation if the ventilator fails to assist breathing properly. Read more at govinfonow.com/recall/68557-hamilton-g5-ventilators-with-software-2-60-risk-of-unassisted.

Source Summary by GovInfoNow · govinfonow.com/recall/68557-hamilton-g5-ventilators-with-software-2-60-risk-of-unassisted · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1874-2019

Cite this page

“Hamilton G5 Ventilators with Software <= 2.60 Risk of Unassisted Breathing.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68557-hamilton-g5-ventilators-with-software-2-60-risk-of-unassisted. Based on FDA recall #Z-1874-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1874-2019%22&limit=1).

The FDA announced on March 25, 2019, that Hamilton Medical AG is recalling HAMILTON-G5 ventilators with software versions less than or equal to 2.60. The devices may enter an ambient state where patients breathe room air unassisted, requiring immediate alternative ventilation.

How to tell if you have it

  • Brand: Hamilton Medical
  • Product: HAMILTON-G5/S1 ventilators
  • Software versions: less than or equal to 2.60
  • Serial numbers: 16192 and lower

The hazard

The hazard is that the new software version reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When this occurs, alternative ventilation must be provided immediately.

Context

GovInfoNow's records show Hamilton Medical AG has 11 other recalls on record since March 9, 2018. Other recent recalls of similar products include Hamilton Medical Breathing Circuit Sets Risk: Exhalation Obstruction During Ventilation (May 29, 2026) and Hamilton Medical IntelliCuff Recall: Cuff System Leakage Error Risk (May 22, 2026). Additional recent recalls of similar products include Philips Respironics Trilogy EV300 Ventilator Software Update Risk (March 2, 2026) and Philips Respironics Trilogy Evo Universal Ventilator: Obstruction Alarm May Not Trigger (March 2, 2026).

How to tell if you have this one

Check if your ventilator has a serial number 16192 or lower. The software version should be 2.60 or older to be affected.

  • Brand
    Hamilton Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on your Hamilton G5/S1 ventilator; versions 2.60 or older are affected.

  2. Contact Manufacturer

    Reach out to Hamilton Medical for guidance on next steps if your ventilator is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 42 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution- US (Nationwide Distribution): MI, WI, OR, MO, TX, NV, PA, SC, HI, MN, ND, NC, AZ, FL, CA, MA, GA, NY, VA, WA, IN, CO, LA, IL, OH, TN, SD, OK, MI, AR, C, AK, WV, NJ, IA, NE, KS, MT, NH, AL, MD, KY, CT, and RI. And…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 5.2 years after the firm started it.

1. Firm started the recall: Mar 25, 201912. FDA classified it Class I: Jul 11, 201923. Published in FDA’s Enforcement Report: Jul 17, 201934. FDA terminated the recall: Jun 3, 2024420192024
  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.

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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-1874-2019 (March 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1874-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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