FDA Announces Hamilton Medical Inc. Recall of Hamilton-C1, C2, C3, T1 Ventilators
This recall is defined by the FDA as Class I, known to be the most severe type given the use of such recalled products could result in harm to users.
The US Food and Drug Administration (FDA) announced a new Class I recall—the most severe form of recall—of certain Hamilton ventilators. Users typically employ these devices to provide complete or partial respiratory assistance through mechanical means.
The company Hamilton Medical Inc. recalled the Hamilton-C1, C2, C3, and T1 ventilators as a result of reports of software complications that could lead to a potential unexpected cessation of ventilator functioning.
The announcement included a note that the devices are operated continuously for over 91 days without a reboot, and can transition to an 'Ambient State.'
The FDA’s release also noted that medical professionals use these ventilators when transferring their patients within and outside medical facilities. The devices are suitable for adults, children, and optionally for infants as well as newborns.
The continued utilization of the recalled ventilator devices could lead to severe harm or loss of life among users, which is why the FDA classified Hamilton Medical Inc.’s recall as Class I.
The FDA release included an additional note that the distribution period had been December 10, 2010, to May 1, 2023, with the number of devices that had been recalled within the US being 21,429.
The product names for the recalled ventilators included the following:
- HAMILTON-C1 with software version <2.2.10 and the neonatal option added.
- HAMILTON-C2 with software version <2.2.5 and the neonatal option added.
- HAMILTON-C3 with software version <2.0.9 and the neonatal option added.
- HAMILTON-T1 with software version <2.2.10 and the neonatal option added.
The product codes included by the FDA’s release included the following:
- HAMILTON C1 Ventilator REF: 161001/1610010
- HAMILTON C2 Ventilator REF: 160001
- HAMILTON C3 Ventilator REF: 160005
- HAMILTON T1 Ventilator REF: 161006/1610060/161009/1610090
The products’ model numbers include the following:
- C1, T1 V2.2.x and earlier
- C2 (all)
- C3 (all)
For further information, view the FDA announcement about the recall here.
