Summary
The FDA issued a Class III for HAMILTON-H900 Humidifier, Models: 950001, 950004 by Hamilton Medical AG. Reason: When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, a.
Details
Source
Device Recall
External ID
Z-1385-2022
Action Date
2022-07-20
Status
Completed
Category
device
Product Description
HAMILTON-H900 Humidifier, Models: 950001, 950004
Lot/Code Info: UDI:07630002801546. All devices with software version 1.10c
Quantity Affected: 203
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.
Distribution
US: WI, FL, CA, NV, PA, TX, PA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-01-05
Company
Bonaduz
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hamilton Medical AG has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hamilton Medical AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hamilton Medical AG have FDA actions?
Hamilton Medical AG has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1385-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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