Reno, NV, United States
Hamilton Medical, Inc. recalls
3 recalls recorded since 2018, most recently on 26 July 2023. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 26 July 2023
- 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.
- Distribution
- Distribution US nationwide, including Puerto Rico. OUS: Not provided
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2529-2023, Z-2526-2023, Z-2528-2023, Z-2525-2023, Z-2530-2023, Z-2527-2023
- Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
- Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
- Hamilton-MR1, REF: 161010, Intensive Care Ventilator
- Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
- Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
- Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Ongoing Class I Medical devices
- Recall started
- 15 June 2023
- Reason
- Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
- Distribution
- U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina No
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2142-2023, Z-2140-2023, Z-2141-2023, Z-2139-2023
- HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Ongoing Class II Medical devices
- Recall started
- 20 June 2017
- Reason
- Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
- Distribution
- US Distribution to IL and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0335-2018
- Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.