Recall Z-0151-2016 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical, Inc.
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
| Date | Nov 4, 2015 (initiated Apr 22, 2014) |
| Status | Terminated |
| Reason | Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult). |
| Root cause | Device Design |
| Action | Hamilton Medical issued a letter dated April 22, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that their Hamilton Medical Account Manager would contact them to coordinate the deactivation of the Ventilation Suppression feature. Customers were asked to review the Medical Device Field Safety Corrective Action. Customers with questions were instructed to call 800-426-6331, Ext 215. |
| Quantity | 1128 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131774 | HAMILTON-G5 Hamilton Medical AG, Oct 9, 2013 |