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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 76
Distribution
Part of a larger recall action
This product is one of 6 recalled by Hamilton Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Hamilton Medical, Inc.
See all →- SevereVentilator Control Board Spare Parts Recalled Due to Electrical Short-Circuit Risk
FDA (Devices) · 2023-09-27
- SevereHamilton-T1 Ventilator Recall: Degrading Capacitors May Interrupt Ventilation
FDA (Devices) · 2023-09-27
- SeverePortable Intensive Care Ventilator Recalled for Degrading Capacitor Issue
FDA (Devices) · 2023-09-27
- SevereVentilator Spare Parts Recalled for Degrading Capacitor Risk
FDA (Devices) · 2023-09-27
- SevereIntensive Care Ventilators Recalled Due to Capacitor Degradation Risk
FDA (Devices) · 2023-09-27
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