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.
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 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.
- Affected units
- 1,216
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 →- SevereIntensive Care Ventilators Recalled Due to Capacitor Degradation Risk
FDA (Devices) · 2023-09-27
- SevereVentilator Spare Parts Recalled for Degrading Capacitor Risk
FDA (Devices) · 2023-09-27
- SevereHamilton-T1 Ventilator Recalled Due to Degrading Capacitors That May Interrupt Ventilation
FDA (Devices) · 2023-09-27
- SeverePortable Intensive Care Ventilator Recalled for Degrading Capacitor Issue
FDA (Devices) · 2023-09-27
- SevereVentilator Control Board Spare Parts Recalled Due to Electrical Short-Circuit Risk
FDA (Devices) · 2023-09-27
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