HAMILTON-H900 Humidifier, Models: 950001, 950004
Check against the official notice below — it lists the full affected range.
The Hamilton Medical AG HAMILTON-H900 Humidifier (Models 950001 and 950004) is subject to recall due to a safety issue with its low water level alarm. When the humidifier is started with an empty chamber and no water is added, the alarm that alerts medical staff to the low water level is delayed, potentially leaving staff unaware that there is no water in the chamber. These humidifiers are used during invasive and noninvasive mechanical ventilation to condition respiratory gases. A total of 203 devices have been distributed in the United States across Wisconsin, Florida, California, Nevada, Pennsylvania, and Texas.
The recalled humidifiers are identified by UDI 07630002801546 and have software version 1.10c. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.
Reason for recall: When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber. Distribution: US: WI, FL, CA, NV, PA, TX, PA Quantity: 203 Lot/code info: UDI:07630002801546. All devices with software version 1.10c
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.