Intensive Care Ventilators Recalled Due to Capacitor Degradation Risk
Hamilton Medical is recalling 12 intensive care ventilators (model Hamilton-MR1) due to degrading capacitors that may leak electrolyte, potentially causing ventilation interruption. The recall affects specific serial numbers across 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 medical device recall, which requires a minimum score of 4. The hazard involves potential interruption of ventilation in life-critical equipment. Although no illnesses or injuries have been reported, the failure mechanism is confirmed (degrading capacitors), and the consequences are serious for patients dependent on the device.
Plain-English summary
Hamilton Medical, Inc. is recalling 12 units of the Hamilton-MR1 intensive care ventilator (REF: 161010) due to a defect in the control board capacitors.
The recalled ventilators have capacitors that may degrade over time and leak electrolyte onto the control board. This electrolyte leakage can cause a short circuit on the board or cause the capacitor to lose function. Either failure could interrupt ventilation delivery to patients.
The affected units were distributed nationwide across the United States, including Puerto Rico. The specific serial numbers are: 3422, 3423, 3424, 3425, 3426, 3427, 3428, 3429, 3469, 3503, 3510, 3800. Consumers who own or operate these units should check their serial numbers and contact Hamilton Medical for replacement or repair instructions.
The recalled product
- Product
- Hamilton-MR1, REF: 161010, Intensive Care Ventilator
- Manufacturer
- Hamilton Medical, Inc.
- Category
- Medical Device — Ventilators
- Hazard
- capacitor-degradation
- electrical-failure
- ventilation-interruption
Distribution
Distributed nationwide across the United States.
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