Hamilton C3 ventilator software anomaly may cause unexpected device stoppage
A software anomaly in the Hamilton C3 Ventilator may cause it to unexpectedly stop and enter ambient mode without warning after approximately 91 days of use. Approximately 701 systems are affected.
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 establishes the serious potential for harm from this software anomaly in a critical respiratory support device. The ventilator may stop unexpectedly after 91 days of use, potentially cutting off life-sustaining ventilation support.
Plain-English summary
The FDA has issued a Class I recall for the Hamilton C3 Ventilator (REF 160005), manufactured by Hamilton Medical, Inc. The device is intended to provide positive pressure ventilatory support to adults, pediatrics, and optionally infants and neonates. A software anomaly has been identified that may cause the ventilator to unexpectedly stop and enter ambient mode without prior warning after approximately 91 days of cumulative use.
Approximately 701 systems are affected. Distribution includes all U.S. states, Puerto Rico, and internationally in the Bahamas, Japan, and Mexico. The specific serial numbers of affected units are documented in FDA recall records.
Individuals with affected Hamilton C3 Ventilators should verify their device serial number against the recall list and contact the manufacturer or FDA for guidance.
The recalled product
- Product
- HAMILTON C3 Ventilator REF 160005 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
- Hazard
- software-anomaly
- device-stoppage
- loss-of-ventilation
Distribution
Distribution scope not specified by the agency.
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