Device product
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Z-0426-2014
Product summary
- Event
- Event 65985
- Status
- Terminated
- Classification
- Class II
- Quantity
- 118
- Official record key
device-enforcement:Z-0426-2014
Official wording
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.
Code information: Multiple serial numbers
Distribution pattern: Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
Derived failure modes
-
Unknown
Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.