Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended t
Summary
The FDA issued a Class I for Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW by Hamilton Medical AG. Reason: A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at .
Details
Source
Device Recall
External ID
Z-2328-2025
Action Date
2025-08-27
Status
Ongoing
Category
device
Product Description
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
Lot/Code Info: Model/Catalog Number: 160021 ESM board Part Number: 10144626 GTIN: 07630002808590 UDI-DI: 76300028PN160021ZW Affected SN range: 13636 till 13950 and 13966 till 14753 13797 13801 13806 13855 13865 13981 13988 13989 14012 14015 14019 14034 14035 14042 14052 14054 14102 14109 14112 14113 14114 14115 14116 14119 14120 14121 14122 14123 14124 14126 14127 14128 14163 14168 14169 14170 14172 14173 14175 14177 14187 14188 14189 14195 14197
Quantity Affected: 1040 systems
Reason for Recall
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-03
Company
Domat/Ems, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 135 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-2328-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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