Recall – Ventilator error may cause unit to permanently enter ambient state

Company: Hamilton Medical
Date of Enforcement Report: 7/12/2019
Class I


Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)

Recall Number: Z-1874-2019


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.


Hamilton Medical on 3/25/2019. Voluntary:  Firm Initiated recall is ongoing.

4338 units


US Nationwide and International

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to by Sep 25, 2019 if possible!

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.