FDAFDA · Food and drugs·Recall number Z-2529-2023
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Published September 27, 2023 · Recall initiated: July 26, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hamilton Medical, Inc.
- Distributor
- Distribution US nationwide, including Puerto Rico. OUS: Not provided
- Lot
- UDI: 07630002805247 / Affected Serial Numbers: 4001901, 4002139, 4003445, 4003567, 4003576, 4005595
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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