HAMILTON-H900 Humidifier Recall Due to Delayed Low-Water Alarm
Hamilton Medical's HAMILTON-H900 humidifier (models 950001, 950004) is recalled due to delayed low-water level alarms that may prevent medical staff from detecting an empty chamber during mechanical ventilation use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device used in critical mechanical ventilation applications where a delayed warning alarm could prevent detection of an empty water chamber, potentially resulting in inadequate gas conditioning during patient respiratory support. No injuries have been reported, meeting the rubric criterion for score 3.
Plain-English summary
Hamilton Medical AG is recalling the HAMILTON-H900 Humidifier, models 950001 and 950004 (UDI: 07630002801546, software version 1.10c), used for respiratory gas conditioning during invasive and noninvasive mechanical ventilation. When the device is started with an empty chamber and no water is filled in, the low water level alarm is delayed, potentially preventing medical staff from being promptly alerted that no water is present.
The recall affects 203 humidifiers distributed to healthcare facilities in multiple U.S. states including Wisconsin, Florida, California, Nevada, Pennsylvania, and Texas.
Healthcare providers using affected humidifiers should ensure water is properly filled into the chamber before each use and verify water presence through visual inspection rather than relying solely on the low-water alarm. Facilities should contact Hamilton Medical AG for further guidance regarding affected devices.
The recalled product
- Product
- HAMILTON-H900 Humidifier, Models: 950001, 950004
- Manufacturer
- Hamilton Medical AG
- Affected units
- 203
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI:07630002801546. All devices with software version 1.10c
Distribution
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