HAMILTON-H900 Humidifier, Models: 950001, 950004 recallZ-1385-2022 · Hamilton Medical AG · initiated Jan 5, 2021
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hamilton Medical AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1385-2022
- Status
- Completed
- Initiated by the company
- Jan 5, 2021
- Recalling firm
- Hamilton Medical AG
- Quantity
- 203
- Product code
- BTT
- FDA submissions
- K163283
- Distribution
- US: WI, FL, CA, NV, PA, TX, PA
Product description
HAMILTON-H900 Humidifier, Models: 950001, 950004
Code information (models, lots, serial numbers)
UDI:07630002801546. All devices with software version 1.10c
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HAMILTON-H900 950004Hamilton Medical AG · Humidifier, Respiratory Gas, (Direct Patient Interface)1 recall1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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