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.
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 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
- Affected units
- 12
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 →- SevereHamilton-T1 Ventilator Recall: Degrading Capacitors May Interrupt Ventilation
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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