Ventilator HAMILTON-C6 may fail to restart, risking oxygen deprivation
Hamilton Medical AG is recalling the HAMILTON-C6 ventilator due to a sensor failure that may prevent re-initiation after reconnection, potentially causing hypoxia.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. The failure mode could result in hypoxia (oxygen deprivation), a serious threat to patient safety. Although the incident requires a specific sequence of user actions and no illnesses have been reported, the Class I classification mandates a minimum severity score of 4.
Plain-English summary
Hamilton Medical AG is recalling the Ventilator HAMILTON-C6 (Part Number 160021) due to a critical sensor failure issue. Under specific conditions—when a user administers oxygen enrichment followed by endotracheal tube disconnection for suctioning—the ventilator may enter sensor fail mode. If the patient is then reconnected while the ventilator remains in fail mode, the ventilation may not re-initiate, potentially causing hypoxia (oxygen deprivation).
This recall affects 68 units distributed nationwide across the United States, including units in Georgia, Kentucky, Florida, Indiana, Nevada, Michigan, Virginia, Oregon, Texas, South Carolina, California, and Pennsylvania. Affected units operate on software versions 1.1.4, 1.1.5, or 1.1.6 and can be identified by UDI 07630002808590.
Healthcare providers and facilities operating affected units should immediately cease use and contact Hamilton Medical AG for instructions. Patients and caregivers should ensure medical personnel are aware of this recall if the device is in use in a clinical setting.
The recalled product
- Product
- Ventilator HAMILTON-C6, PN: 160021
- Manufacturer
- Hamilton Medical AG
- Affected units
- 68
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI: 07630002808590
- Software Versions: SW v1.1.4
- SW v1.1.5
- SW v1.1.6
Distribution
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