Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland HAMILTON-H900 Humidifier, Models: 950001, 950004 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HAMILTON-H900 Humidifier, Models: 950001, 950004
Brand
Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland
Lot Codes / Batch Numbers
UDI:07630002801546. All devices with software version 1.10c
Products Sold
UDI:07630002801546. All devices with software version 1.10c
Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland is recalling HAMILTON-H900 Humidifier, Models: 950001, 950004 due to When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 01/05/21, Field Safety Corrective Action notices were sent to customers who were asked to do the following: Follow the instructions in the HAMILTON-H900 Operator s Manual 624431 section 3.4. Before connecting a new patient to the humidifier; " Verify that the alarms operate correctly. " Ensure that the water supply to the humidifier chamber is functioning properly. Distribute this notification to all end users within your organization. A Medical Representative will be in contact to schedule service with a software update. Customers with additional questions or concerns were encouraged to call Technical Support at 1-800-426-6331, option #2.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, NV, PA, TX, WI
Page updated: Jan 10, 2026