The Recall Desk

FDA (Devices) recall action 80467

Hamilton Medical AG recalled 2 products on 2018-08-22

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-08-22
Critical
0
Units
18

Why these products were recalled

An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-08-22

    Hamilton-C3 Ventilator Recalled Due to Control Board Component Defect

    Hamilton Medical AG is recalling two Hamilton-C3 ventilators because an out-of-specification control board component may cause the device to shut down and trigger alarms.

    Product
    Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care…
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2018-08-22

    Hamilton-C1 Ventilator Recall Due to Control Board Component Defect

    Hamilton Medical AG is recalling 16 Hamilton-C1 ventilators because a defective control board component may cause the device to shut down and trigger alarms.

    Product
    Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients…
    Category
    Distribution
    9 states