medical Class I Updated 2019-07-17

Hamilton Medical AG recalls HAMILTON-G5, with software versions less than or equal to 2.

Recalled 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 institutional environment where health care professionals provide patient care.


Hazard / Issue

New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial numbers 16192 and lower
View official government recall

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