Recall Z-1185-2012 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical Inc
HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. Product Usage: Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional envir
| Date | Mar 7, 2012 (initiated Feb 6, 2012) |
| Status | Terminated |
| Reason | Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions. |
| Root cause | Software design |
| Action | Hamilton Medical sent a Medical Device Safety Alert and Correction Action letter dated February 17, 2011 to all affected customers via a traceable method. The letter identified the affected product, problem and immediate actions required by operators, distributor and manufacturer. The letter states that a Hamilton Medical Account manager will contact customers to schedule a convenient time for the Technical Support Department to install the software update. Questions or concerns may be directed to Technical Support Manager at 800-426-6331, Ext 125. |
| Quantity | 456 devices in US. |
| Distribution | (USA) Nationwide Distribution including the states of: CA, CO, FL, GA, MA, MI, MO, NC, NV, NY, PA, TN, TX, VA and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103803 | HAMILTON-G5 Hamilton Medical AG, Nov 23, 2011 |