Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Alarm Suppression Defect
Hamilton Medical is recalling 1,128 HAMILTON-G5 ventilators because suctioning maneuvers can unintentionally suppress ventilation and alarms.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classified this recall as FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Hamilton Medical, Inc. is recalling 1,128 HAMILTON-G5 ventilators with software versions between V2.00 and V2.31. The affected devices are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The recall covers units distributed nationwide.
The recall is due to a defect where ventilation and alarms can be suppressed unintentionally after the activation of a suctioning maneuver by the operator. This situation can occur regardless of the selected patient group, including neonatal, pediatric, and adult patients. The agency has classified this recall as Class I.
Healthcare facilities should identify affected units by checking the software version and serial numbers listed in the recall notice. Operators should follow the instructions provided by Hamilton Medical to mitigate the risk of unintentional alarm and ventilation suppression.
The recalled product
- Product
- HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
- Manufacturer
- Hamilton Medical, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 1,128
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 (1)
- software versions between V2.00 and V2.31. Ventilator catalog number: 1590001
Distribution
Distributed nationwide across the United States.
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