Recall Z-2529-2023— Hamilton Medical, Inc.
Class I · Ongoing
Class I FDA medical device recall by Hamilton Medical, Inc., initiated 2023-07-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator. Reason: Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation..
- Recalling firm
- Hamilton Medical, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-07-26
- Firm location
- Reno, NV, United States
Product description
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Reason for recall
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.