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.
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 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
- Affected units
- 701
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.
See all 4 products in this recall →Related recalls
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