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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Hamilton C6 Ventilators Recalled for Defective Circuit Board and Failure Risk

Agency Publication Date: August 19, 2025
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Summary

Hamilton Medical AG is recalling 1,040 Hamilton C6 ventilators due to a mechanical defect on a printed circuit board. This defect may cause the ventilator to fail during startup or stop providing air to the patient by entering an 'ambient state' during use. While no injuries have been reported, this failure results in a dangerous interruption of mechanical ventilation for patients.

Risk

The defective circuit board can cause the ventilator to suddenly stop working. If this occurs while a patient is connected, the interruption of breathing support can lead to serious health complications, respiratory distress, or death.

What You Should Do

  1. This recall affects Hamilton C6 Ventilators (REF 160021) equipped with ESM Board Part Number 10144626.
  2. Identify if your ventilator is affected by checking the serial number on the device label. Affected serial number ranges include 13636 through 13950 and 13966 through 14753, as well as dozens of individual unit numbers. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device.
  4. Contact Hamilton Medical AG or your authorized distributor to arrange for a return, replacement, or correction of the device.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Hamilton C6 Ventilator
Model / REF:
160021
10144626
Serial Numbers:
13636 till 13950
13966 till 14753
13797
13801
13806
13855
13865
13981
13988
13989
14012
14015
14019
14034
14035
14042
14052
14054
14102
14109
14112
14113
14114
14115
14116
14119
14120
14121
14122
14123
14124
14126
14127
14128
14163
14168
14169
14170
14172
14173
14175
14177
14187
14188
14189
14195
14197
UDI:
76300028PN160021ZW
GTIN:
07630002808590

Includes ESM Board Part Number 10144626. The Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97079
Status: Active
Manufacturer: Hamilton Medical AG
Sold By: Authorized Hamilton Medical distributors
Manufactured In: Switzerland
Units Affected: 1040 systems
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.