Hamilton Medical AG: HAMILTON-C6 Ventilator Recalled for Critical Ventilation Failure Risk

Agency Publication Date: June 18, 2024

Summary

Hamilton Medical AG is recalling 68 HAMILTON-C6 ventilators because a specific sequence of actions during patient care can cause the device to stop breathing for the patient. If a healthcare provider uses the oxygen enrichment feature and disconnects the patient for suctioning, the ventilator may enter a 'sensor fail' mode and fail to restart ventilation once the patient is reconnected. This defect affects model number 160021 with software versions 1.1.4, 1.1.5, and 1.1.6.

Risk

If the ventilator fails to re-initiate breathing after being reconnected to a patient, it can lead to hypoxia (critically low oxygen levels), which may result in serious injury or death.

What You Should Do

Identify if your facility is using the HAMILTON-C6 Ventilator (Part Number 160021) by checking the device nameplate and verifying the software version is v1.1.4, v1.1.5, or v1.1.6.
Check the device for the specific UDI (Unique Device Identifier) 07630002808590 to confirm it is part of the affected 68 units.
Immediately contact your healthcare provider or Hamilton Medical AG to discuss safety protocols and necessary software updates or device inspections.
If you are a healthcare provider, ensure staff are aware that if a 'sensor fail' occurs during oxygen enrichment and suctioning, the device may not automatically resume ventilation upon reconnection.
Contact Hamilton Medical AG directly via their Swiss headquarters at Via Crusch 8, Bonaduz, Switzerland, or through your local authorized representative for further instructions regarding this voluntary recall.
For additional information or to report adverse events, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Technical Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Ventilator HAMILTON-C6

Model / REF:

PN: 160021

SW v1.1.4

SW v1.1.5

SW v1.1.6

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94671

Status: Active

Manufacturer: Hamilton Medical AG

Sold By: Authorized Medical Distributors

Manufactured In: Switzerland

Units Affected: 68

Distributed To: Georgia, Kentucky, Florida, Indiana, Nevada, Michigan, Virginia, Oregon, Texas, South Carolina, California, Pennsylvania

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 · 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.

Summary

What You Should Do

Identify if your facility is using the HAMILTON-C6 Ventilator (Part Number 160021) by checking the device nameplate and verifying the software version is v1.1.4, v1.1.5, or v1.1.6.

Check the device for the specific UDI (Unique Device Identifier) 07630002808590 to confirm it is part of the affected 68 units.

Immediately contact your healthcare provider or Hamilton Medical AG to discuss safety protocols and necessary software updates or device inspections.

If you are a healthcare provider, ensure staff are aware that if a 'sensor fail' occurs during oxygen enrichment and suctioning, the device may not automatically resume ventilation upon reconnection.

Contact Hamilton Medical AG directly via their Swiss headquarters at Via Crusch 8, Bonaduz, Switzerland, or through your local authorized representative for further instructions regarding this voluntary recall.

For additional information or to report adverse events, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.