Ventilator HAMILTON-C6, PN: 160021 recallZ-2020-2024 · Hamilton Medical AG · initiated May 15, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hamilton Medical AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging change control
What the company is doing
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 [email protected] - 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 [email protected]
Recall details
- Recall number
- Z-2020-2024
- Status
- Open, Classified
- Initiated by the company
- May 15, 2024
- Posted by the FDA
- Jun 18, 2024
- Recalling firm
- Hamilton Medical AG
- Quantity
- 68
- Product code
- CBK
- FDA submissions
- K201658
- Distribution
- US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
Product description
Ventilator HAMILTON-C6, PN: 160021
Code information (models, lots, serial numbers)
UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page