Hamilton Medical AG medical device recall: Hamilton C6 REF 160021
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97079
- Recall initiated
- Jun 3, 2025
- Classified by FDA
- Aug 19, 2025
- Posted in Enforcement Report
- Aug 27, 2025
- Recalling firm
- Hamilton Medical AG
- Firm location
- Domat/Ems, Switzerland
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jun 3, 2025. FDA classified it 77 days later, on Aug 19, 2025. Distribution reported by FDA: US Nationwide distribution. Hamilton Medical AG has 12 recalls in our records.
Recalled products (1)
Z-2328-2025 Class I Ongoing
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.
Codes / lots: 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: 1040 systems
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97079
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.