Ventilator Spare Parts Recalled for Degrading Capacitor Risk
Hamilton Medical is recalling ventilator spare parts (ESM Shielding Set) due to potentially degrading capacitors on the control board. These capacitors may leak electrolyte and cause a short circuit, interrupting 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: FDA Class I classification mandates a minimum severity score of 4. The affected component is part of a life-critical device (ventilator) where malfunction could interrupt ventilation, potentially causing serious patient harm. No illnesses or deaths have been reported to date.
Plain-English summary
Hamilton Medical, Inc. is recalling the Hamilton-T1 ESM Shielding Set, a spare part for ventilators. The recalled units have Universal Device Identification (UDI) 07630002800761 and specific serial numbers: 4050193, 4050210, 4050194, and 4016669.
The control board in the affected spare parts contains capacitors that may degrade over time. When capacitors degrade, they may leak electrolyte onto the control board. This leakage can cause an electrical short circuit or cause the capacitor itself to lose function.
If a short circuit or capacitor malfunction occurs, the ventilator may experience an interruption of ventilation. This can be life-threatening for patients who depend on mechanical ventilation. The affected spare parts were distributed nationwide in the United States, including Puerto Rico.
Patients and healthcare providers who use or maintain affected Hamilton-T1 ventilators should contact Hamilton Medical for further instructions. The FDA has classified this as a Class I recall, indicating that the issue poses a serious risk of harm.
The recalled product
- Product
- Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
- Manufacturer
- Hamilton Medical, Inc.
- Hazard
- capacitor-degradation
- electrolyte-leak
- short-circuit
- ventilation-interruption
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI: 07630002800761 / Affected Serial Numbers: 4050193
- 4050210
- 4050194 and 4016669
Distribution
Distributed nationwide across the United States.
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