Recall Z-0426-2014 ยท KOG
Custom Ultrasonics, Inc.
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
| Date | Nov 27, 2013 (initiated Mar 12, 2013) |
| Status | Terminated |
| Reason | Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. |
| Root cause | Software design |
| Action | A notification letter, dated February 26, 2013, was sent to direct accounts to inform them of the recall and that technicians would visit facilities to replace the Windows 7 operating system with an appropriately validated Windows XP operating system. |
| Quantity | 118 |
| Distribution | Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru. |
| FDA record | Open on fda.gov |