HAMILTON-H900 Humidifier, Models: 950001, 950004
FDA Recall Z-1385-2022 · Posted None
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Recalling FirmHamilton Medical AG
Recall StatusCompleted
Product CodeBTT
Date Initiated2021-01-05
Product Quantity203
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
US: WI, FL, CA, NV, PA, TX, PA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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