HAMILTON C1 Ventilator Recalled for Software Defect Causing Unexpected Shutdown
Hamilton Medical is recalling 689 HAMILTON C1 Ventilators due to a software defect that causes unexpected shutdown after approximately 91 days of use. The device may enter ambient mode without notice, interrupting ventilatory support.
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: This is an FDA Class I recall of a critical medical device used for life-support. Although no illnesses or injuries are reported in the source text, FDA Class I designation indicates reasonable probability of serious adverse health consequences. A ventilator that unexpectedly ceases operation directly threatens life-critical respiratory support, and per the rubric, Class I recalls never score below 4.
Plain-English summary
Hamilton Medical is recalling the HAMILTON C1 Ventilator, a respiratory support device intended to provide positive pressure ventilatory support to adults and pediatric patients, and optionally infants and neonates. A total of 689 units are affected. Affected devices can be identified by Model HAMILTON-C1 (REF 161001) and by checking their serial number against the manufacturer's published recall list.
A software anomaly has been identified in these units that causes the ventilator to unexpectedly stop operating and enter ambient mode without any prior notice. This defect typically occurs after approximately 91 days of cumulative use. For patients dependent on mechanical ventilation, such an unexpected shutdown could interrupt critical life-support function.
The affected devices were distributed to healthcare facilities throughout the United States, including all 50 states and Puerto Rico, as well as internationally in the Bahamas, Japan, and Mexico. Any healthcare facility using HAMILTON C1 Ventilators should verify whether any of their units have serial numbers matching those on the recall list.
Healthcare providers and patients currently using potentially affected units should contact Hamilton Medical, Inc. immediately for instructions. The manufacturer will provide guidance on appropriate repair, replacement, or other corrective measures. Patients should not continue operating a ventilator confirmed to be on the recall list until receiving instructions from the manufacturer.
The recalled product
- Product
- HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Manufacturer
- Hamilton Medical, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 689
Distribution
Part of a larger recall action
This product is one of 4 recalled by Hamilton Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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