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.
- Company
- Hamilton Medical Inc
- Recall Initiated
- March 24, 2015
- Posted
- July 10, 2015
- Terminated
- December 23, 2015
- Recall Number
- Z-2057-2015
- Quantity
- 248
- Firm Location
- Reno, NV
Reason for Recall
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.
Distribution
Nationwide Distribution
Lot / Code Info
Software version 2.20 and 2.41,
Root Cause
Device Design
Action Taken
*** 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.