Z-2328-2025Class I

Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator...

Name: Z-2328-2025 Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator...
Creator: Hamilton Medical AG
Published: 2025-06-03
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2025-06-03 / Open, Classified / root cause: manufacturing process

FDA source

Hamilton Medical AG began a recall of Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory... on 2025-06-03. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2328-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-06-03
Posted: 2025-08-19
Recalling firm: Hamilton Medical AG
Product: 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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: URGENT: Medical Device Correction letters were emailed to customers on 06/06/2025, 06/20/2025, and 07/07/2025, informing them that due to damage to the capacitor in the ESM-Board within the Hamilton-C6 ventilator the capacitor could, over time, lead to a loss of its function due to oxidation of similar degradation processes. Customers are instructed to: 1. Review their Hamilton-C6 ventilators and check for the serial number within the scope mentioned in the letter. 2. for affected ventilators must have the ESM-Boards replaced. The replacement will be organized by the local partner as per servicing protocol. Note - the Hamilton-C6 ventilators do not need to be removed from use/service. These devices were tested prior to release and no test will be able to detect if the ESM board will fail in the future. 3. Keep the recall notice within the respective ventilator's data records. For questions or assistance, contact Technical Support at 1-800-426-6331 option 2 or email [email protected]
Quantity in commerce: 1040 systems
Distribution: US Nationwide distribution.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2328-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2328-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-19

Product code CBK

K201658Class IIHamilton-C6Hamilton Medical AG / cleared 2020-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)