Z-1385-2022Class III

HAMILTON-H900 Humidifier, Models: 950001, 950004

Name: Z-1385-2022 HAMILTON-H900 Humidifier, Models: 950001, 950004
Creator: Hamilton Medical AG
Published: 2021-01-05
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2021-01-05 / Completed / root cause: manufacturing process

FDA source

Hamilton Medical AG began a recall of HAMILTON-H900 Humidifier, Models: 950001, 950004 on 2021-01-05. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1385-2022
Classification: Class III
Status: Completed
Initiated: 2021-01-05
Posted: 2022-07-14
Recalling firm: Hamilton Medical AG
Product: HAMILTON-H900 Humidifier, Models: 950001, 950004
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 203
Distribution: US: WI, FL, CA, NV, PA, TX, PA
Product codes and lots: UDI:07630002801546. All devices with software version 1.10c

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1385-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1385-2022	Class III	Completed	Voluntary: Firm initiated	2022-07-20	2022-07-14

Product code BTT

K163283Class IIHamilton-H900, Hamilton-Bc8010, Hamilton-Bc4010Hamilton Medical AG / cleared 2017-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)