The Recall Desk
SevereFDA (Devices)·Z-2526-2023·Announced 2023-09-27

Hamilton-T1 Ventilator Recalled Due to Degrading Capacitors That May Interrupt Ventilation

Hamilton Medical is recalling 76 Hamilton-T1 ventilators because degrading capacitors on the control board can leak electrolyte, potentially causing interruption of ventilation.

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 FDA Class I recall carries a minimum severity of 4 (Severe) per regulatory classification. Although no reported injuries or deaths are documented, the potential for ventilation interruption in a critical care device represents serious patient harm risk.

Plain-English summary

Hamilton Medical, Inc., is recalling 76 Hamilton-T1 intensive care and transport ventilators (model REF: 161006) due to defective capacitors on the control board. The affected units are distributed nationwide, including Puerto Rico.

The control board capacitors may degrade and leak electrolyte fluid. This leakage can cause a short circuit on the board or cause the capacitor to fail, either of which may lead to interruption of ventilation.

Affected units are identified by specific serial numbers provided in the official FDA recall notice.

The recalled product

Product
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Manufacturer
Hamilton Medical, Inc.
Category
Medical Device — Ventilator
Hazard
  • capacitor-degradation
  • electrical-short-circuit
  • ventilation-interruption

Distribution

Distributed nationwide across the United States.

Related recalls

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