The Recall Desk
SevereFDA (Devices)·Z-2527-2023·Announced 2023-09-27

Hamilton-T1 Ventilator Recall: Degrading Capacitors May Interrupt Ventilation

Hamilton Medical recalls 1,216 Hamilton-T1 ventilators due to degrading capacitors on the control board that may leak electrolyte and interrupt ventilation. The recall affects units distributed nationwide in the US and Puerto Rico.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity of 4 per the rubric. The hazard involves degrading capacitors that can cause interruption of ventilation in an intensive care ventilator, a life-critical device. While no illnesses or injuries are reported, the potential for equipment failure in a critical care context meets the threshold for Severe severity.

Plain-English summary

Hamilton Medical, Inc. is recalling 1,216 units of the Hamilton-T1 (REF: 161009) Intensive Care and Transport Ventilator. The recall covers units distributed nationwide in the United States and Puerto Rico.

The defect involves capacitors on the control board that may degrade and leak electrolyte, causing a short circuit or loss of capacitor function. The loss of capacitor function may lead to interruption of ventilation in the affected ventilators.

Affected units are identified by serial numbers listed in the FDA recall database (FDA Recall Number Z-2527-2023). Owners and operators of affected equipment should contact Hamilton Medical, Inc. for guidance on remediation.

The recalled product

Product
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Manufacturer
Hamilton Medical, Inc.
Hazard
  • capacitor-degradation
  • electrolyte-leak
  • short-circuit
  • ventilation-interruption

Distribution

Distributed nationwide across the United States.