Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Ambient State Risk
Hamilton Medical is recalling 4,338 HAMILTON-G5 ventilators with software versions 2.60 or lower because they may enter an ambient state, requiring immediate alternative ventilation.
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: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves a critical failure in a life-support device requiring immediate alternative ventilation.
Plain-English summary
Hamilton Medical AG is recalling 4,338 units of the HAMILTON-G5 ventilator with software versions less than or equal to 2.60. The affected devices are identified by serial numbers 16192 and lower. These ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients, in hospital and institutional environments.
The recall is issued because the ventilators have a probability of entering an ambient state. In this state, the inspiratory channel and expiratory valves are opened, allowing the patient to breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately to maintain patient care.
The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous international countries. A new software version for the affected ventilators reduces the probability of the device entering this ambient state. Health care professionals should contact Hamilton Medical AG for details on the software update and recall procedures.
The recalled product
- Product
- HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutio
- Manufacturer
- Hamilton Medical AG
- Category
- Medical Device — Ventilators
- Affected units
- 4,338
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)
- Serial numbers 16192 and lower
Distribution
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