FDA Medical Device Recalls (openFDA)
Hamilton Medical AG: Ventilator HAMILTON-C6, PN: 160021
- Recall number
- Z-2020-2024
- Recalling firm
- Hamilton Medical AG
- Product
- Ventilator HAMILTON-C6, PN: 160021
- Status
- Open, Classified
- Initiated
- 2024-05-15
- Posted
- 2024-06-18
- Terminated
- not on file
- Reason
- Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
- Root cause
- Packaging change control
- Action
- On 5/24/24, correction notices were emailed to customers and distributors and they were asked to do the following: If ventilation is not re-initiated due to this issue, there are 4 ways to reinitiate ventilation: 1) Select and confirm a control setting (even without a change of the value), or 2) Select and confirm a new ventilation mode, or 3)Switch the ventilator to standby mode and restart ventilation from standby mode, or 4) Switch the ventilator off and switch it on again If the user is not able to manually re-initiate ventilation in due time as per one of the 4 ways described above, they might decide to ventilate the patient by alternative means. - Read and sign the confirmation sheet, which can be returned to bret.everett@hamiltonmedical.com - Ensure that your medical staff is aware of the notice content - Attach this letter to each affected device's operator's manual in order to ensure quick access. - The newest available software version 1.2.3 contains the required fix and shall be installed without undue delay. Your local distribution partner will support you with updating your affected devices with high priority. Questions, contact techsupport@hamilton-medical.com
- Quantity
- 68
- Distribution
- US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
- Lot, serial or model codes
- UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6
- 510(k) numbers
- ["K201658"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3001421318
- Firm city
- Bonaduz
- 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