Hamilton Medical Inc is recalling the Hamilton-C1, C2, C3, and T1 ventilators after receiving reports of software issues that may cause the ventilators to stop without notice, according to a US Food and Drug Administration (FDA) notice

The ventilator will switch to “ambient state” if the device is used for more than 91 days without a restart. During the “ambient state” the ventilator will alarm and display a technical fault alert at the top of the screen. This may require a health care professional to intervene, provide air supply to the patient with a manual resuscitating device, and use an alternative device.

Serious consequences or death may result for patients who do not breathe on their own or do not receive immediate intervention. There have been 80 reported complaints, no injuries, and no deaths related to this recall. The FDA has identified this as a Class I recall, the most serious type of recall.

The recalled products are:

  • 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

The product codes are:

The model numbers are:

  • C1, T1 V2.2.x and before
  • C2 (all)
  • C3 (all)

The ventilators were distributed from Dec 10, 2010, to May 1, 2023.  The recall includes 21,429 devices. Hamilton initiated the recall on June 15.

Hamilton ventilators are used for people who require full or partial breathing assistance from a mechanical ventilator. Health care professionals use them during patient transport within or outside hospital settings. The ventilators support adults, children, and optionally infants and newborns.

On June 15, Hamilton sent all affected customers an Important Medical Device Advisory. The letter requested customers to:

  • Provide alternative ventilation immediately.
  • Switch off ventilator power to exit the “ambient state.”
  • Service the ventilator once patient safety is ensured. (After passing the service software the device can be returned to use.)

Customers with questions about this recall should contact Hamilton Medical AG Technical Support at +41 58 610 10 20 or email [email protected]. A complete list of affected devices is available in the Medical Device Recalls database.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax.