Ventilator HAMILTON-C6, PN: 160021
FDA device recall Z-2020-2024 · posted 2024-06-18 · Open, Classified
Recall details
- Recalling firm
- Hamilton Medical AG
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- CBK
- Quantity affected
- 68
- Distribution
- US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
- Date initiated
- 2024-05-15
- Date posted
- 2024-06-18
- Location
- Bonaduz, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Hamilton-C6 (K201658) | Hamilton Medical AG | 2020-12-11 |