Hamilton C2 Ventilator recalled for software anomaly causing loss of function
FDA is recalling 399 Hamilton C2 Ventilators due to a software anomaly that may cause the device to stop unexpectedly after approximately 91 days of use. Affected facilities should verify serial numbers and contact the manufacturer.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates a serious hazard. A life-support ventilator that may suddenly stop without warning poses a critical safety risk due to the device's essential role in patient care.
Plain-English summary
The FDA has issued a Class I recall for the Hamilton C2 Ventilator, a positive pressure ventilatory support device used for adults, pediatric, and optional neonatal patients. A software anomaly can cause the ventilator to stop and enter ambient mode without prior notice after approximately 91 days of cumulative use, creating a serious risk to patient safety.
The recall affects 399 systems distributed across the United States (all 50 states and Puerto Rico), as well as the Bahamas, Japan, and Mexico. Specific serial numbers have been identified.
Healthcare facilities should immediately identify whether they have affected units by checking device serial numbers against the FDA recall notice (Z-2141-2023). Contact Hamilton Medical, Inc., for remediation instructions, which may include software updates or device replacement.
The recalled product
- Product
- HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Manufacturer
- Hamilton Medical, Inc.
- Hazard
- software-anomaly
- device-failure
Distribution
Distribution scope not specified by the agency.
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