FDA Medical Device Recalls (openFDA)
Hamilton Medical AG: HAMILTON-H900 Humidifier, Models: 950001, 950004
- Recall number
- Z-1385-2022
- Recalling firm
- Hamilton Medical AG
- Product
- HAMILTON-H900 Humidifier, Models: 950001, 950004
- Status
- Completed
- Initiated
- 2021-01-05
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 203
- Distribution
- US: WI, FL, CA, NV, PA, TX, PA
- Lot, serial or model codes
- UDI:07630002801546. All devices with software version 1.10c
- 510(k) numbers
- ["K163283"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 3001421318
- Firm city
- Bonaduz
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28