Recall Z-2057-2015 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical, Inc.
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
| Date | Jul 10, 2015 (initiated Mar 24, 2015) |
| Status | Terminated |
| Reason | Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device. |
| Root cause | Device Design |
| Action | *** Please note *** This is not a new recall. An error occurred, and this recall was originally classified as a class I on July 10, 2015. No further action is required. Hamilton Medical AG notified their customers with a letter dated February 19, 2015 and had a fix (SW 2.42) that was available as of February 20th 2015. Hamilton Medical proceeded to send out notification letters the 24th of March 2015 once they compiled the complete and validated list of customers that had the affected software. Customers with questions were instructed to call 800-426-6331, ext.215. |
| Quantity | 248 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |