CLASS I ONGOING Device recall · Reported 27 Aug 2025 · FDA Enforcement Report
Hamilton C6 recalled by Hamilton Medical AG
Hamilton Medical AG is recalling Hamilton C6, distributed nationwide in the US. The recall was initiated on 3 Jun 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2328-2025
- FDA event ID
- 97079
- Recalling firm
- Hamilton Medical AG, Domat/Ems, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 3 Jun 2025
- FDA classified
- 19 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 3 Jun 2025 | Recall initiated by company | |
| 19 Aug 2025 | Classified by FDA | +77 days |
| 27 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Hamilton C6 recalled?
Yes. Hamilton Medical AG recalled Hamilton C6 on 3 Jun 2025. The recall is Class I and its status is Ongoing. Recall number Z-2328-2025.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hamilton Medical AG
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IntelliCuff, Portable automatic cuff pressure controller recalled | Hamilton Medical AG | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial, 80 m, with flow sensor recalled | Hamilton Medical AG | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Ventilator Hamilton-C6, PN recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
| Device | CLASS II | Hamilton-C6, REF recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |