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U.S. Department of Health and Human Services

Class 3 Device Recall HAMILTONH900

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  Class 3 Device Recall HAMILTONH900 see related information
Date Initiated by Firm January 05, 2021
Create Date July 14, 2022
Recall Status1 Completed
Recall Number Z-1385-2022
Recall Event ID 90460
510(K)Number K163283  
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
Product HAMILTON-H900 Humidifier, Models: 950001, 950004
Code Information UDI:07630002801546. All devices with software version 1.10c
Recalling Firm/
Manufacturer		 Hamilton Medical AG
Via Crusch 8
Bonaduz Switzerland
For Additional Information Contact
41816606010
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BTT and Original Applicant = HAMILTON MEDICAL AG
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