Use caution Medical device recall · FDA · Published May 15, 2024

Hamilton Medical Ventilator HAMILTON-C6 Recall: Risk of Hypoxia After Sensor Fail

Hamilton Medical recalls HAMILTON-C6 ventilators with specific software versions due to potential hypoxia if sensor fail mode occurs after patient reconnection. Affected units have UDI 07630002808590 and software versions v1.1.4 to v1.1.6.

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

🇺🇸 FDA recall #Z-2020-2024Medical device Hamilton Medical ›

Use caution until it’s fixed

Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.

Take action

Contact the company

Recalling firmHamilton Medical AGVia Crusch 8 · Bonaduz, Switzerland

✎ GovInfoNow plain-language explainer

Hamilton Medical is recalling ventilators with specific software versions that may cause hypoxia if a sequence of user actions triggers sensor fail mode. This could lead to insufficient oxygen delivery during critical patient care. Read more at govinfonow.com/recall/55107-hamilton-medical-ventilator-hamilton-c6-recall-risk-of-hypoxia-after.

Source Summary by GovInfoNow · govinfonow.com/recall/55107-hamilton-medical-ventilator-hamilton-c6-recall-risk-of-hypoxia-after · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2020-2024

Cite this page

“Hamilton Medical Ventilator HAMILTON-C6 Recall: Risk of Hypoxia After Sensor Fail.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55107-hamilton-medical-ventilator-hamilton-c6-recall-risk-of-hypoxia-after. Based on FDA recall #Z-2020-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2020-2024%22&limit=1).

The FDA announced on May 15, 2024, that Hamilton Medical AG is voluntarily recalling the HAMILTON-C6 ventilator (PN: 160021) due to a Class I hazard. The device may fail to re-initiate ventilation after a sensor error, potentially causing patient hypoxia.

How to tell if you have it

Brand: Hamilton Medical
Product: Ventilator HAMILTON-C6
Part Number: PN: 160021
UDI: 07630002808590
Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6

The hazard

The ventilator may enter a sensor fail mode where ventilation does not re-initiate after the patient is reconnected following an O2 enrichment and tube disconnection sequence. This failure can cause hypoxia, according to the FDA record.

Context

GovInfoNow's records show Hamilton Medical AG has 11 other recalls on record since March 9, 2018. Recent brand recalls include a breathing circuit set risk dated May 29, 2026, and an IntelliCuff leakage error dated May 22, 2026. Other recent recalls of similar products include the Baxter Blue Ventilator Adapter Module Recall (Feb. 18, 2026) and the Draeger Atlan A350 Anesthesia Workstation Recall (May 7, 2026).

How to tell if you have this one

Check for the UDI code 07630002808590 and software versions v1.1.4 through v1.1.6 on the ventilator's label. The product was sold with these specific software versions.

Brand
Hamilton Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Review the ventilator's software version to confirm it is v1.1.4, v1.1.5, or v1.1.6.
Monitor for Symptoms
If the ventilator fails to restart after reconnection, check for signs of hypoxia such as shortness of breath or low oxygen levels.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 12 states.

FDA distribution: “US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Georgia, Indiana, Kentucky, Michigan, Nevada, Oregon, Pennsylvania, South Carolina, Texas, Virginia.

Recall timeline

FDA published this recall 42 days after the firm started it.

May 15, 2024Firm started the recall
Jun 18, 2024FDA classified it Class I
Jun 26, 2024Published in FDA’s Enforcement Report

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/55107-hamilton-medical-ventilator-hamilton-c6-recall-risk-of-hypoxia-after">Hamilton Medical Ventilator HAMILTON-C6 Recall: Risk of Hypoxia After Sensor Fail (GovInfoNow)</a>

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-2020-2024 (May 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2020-2024 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.