FDA Medical Device Recalls (openFDA)
Hamilton Medical AG: 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.
- Recall number
- Z-2328-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2025-06-03
- Posted
- 2025-08-19
- Terminated
- not on file
- 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 startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
- 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 reno.techsupport@hamiltonmedical.com
- Quantity
- 1040 systems
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K201658"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3014766741
- Firm city
- Domat/Ems
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28