Hamilton Medical recalls more than 20,000 ventilators due to software issues

Key takeaways:

• There have been 80 complaints reported to the FDA, but no injuries or deaths.
• According to the FDA, there are 21,429 affected devices in the United States.

The FDA has designated Hamilton Medical Inc.’s recall of its HAMILTON-C1, C2, C3 and T1 Ventilators as a class I recall, the most serious kind.

The recall is due to software issues that may cause the ventilators to stop without notice. If the ventilators are used for more than 91 days without a restart, the device will switch to an “ambient state,” according to an alert from the FDA.

There are currently 80 reported complaints related to the recall, but no injuries or deaths have been reported. According to the alert, there are 21,429 affected devices in the United States, and these devices were distributed between Dec. 10, 2010, and May 1, 2023.

Hamilton Medical Inc. sent affected customers an Important Medical Device Advisory on June 15 requesting customers to provide alternative ventilation immediately, switch off the ventilator and service the ventilator. The letter said after passing the service software, the device can be used again.

The alert notes that the ventilators are used for patients who require full or partial breathing assistance from a mechanical ventilator. The devices may be used during patient transport or outside hospital settings, and are used to support adults, children and possibly infants and newborns.

Healio previously reported a class I recall of Draeger Medical ventilators this month, and two class I recalls from Draeger Medical and NOxBOX in July.