Hamilton Medical’s ventilator recall was recently given a Class I designation from FDA. The company originally contacted customers in June after learning that its C1, C2, C3, and T1 ventilators with the neonatal option installed received reports of software issues that could cause the machines to stop ventilating without notice.
While Hamilton sells mechanical ventilators for use in adults, children, and infants, it was found that the ventilators would switch to “Ambient State” if “used for long-term ventilation in [the] neonatal group.” Specifically, FDA detailed in the recall notice that if the ventilation time exceeded 91 days, an alarm would sound alerting the machine was entering its ambient state, display a fault message, and stop providing ventilation.
In such an event, FDA wrote that a healthcare provider may have to intervene and provide alternative air supply or manual resuscitation device to the patient. Currently, 21,429 devices distributed between Dec. 10, 2010, and May 1, 2023, have been recalled in the United States due to the issue. The company received 80 complaints but no reported injuries or deaths.
FDA urged healthcare professionals to restart their ventilators regularly to circumvent the issue. Hamilton recommended doing the restarts about every 28 days during the devices regular exchange of breathing circuits. The company also noted that putting the device on standby won’t prevent it from going into ambient state.
The recall is specific to specific Hamilton C1, C2, C3, and T1 ventilators with the neonatal option installed:
- Hamilton-C1 with SW version <2.2.10 and neonatal option installed
- Hamilton-C2 with SW version <2.2.5 and neonatal option installed
- Hamilton-C3 with SW version <2.0.9 and neonatal option installed
- Hamilton-T1 with SW version <2.2.10 and neonatal option installed