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Custom Ultrasonics, Inc. recalls Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Recalled December 4, 2013 · FDA recall Z-0426-2014 · Custom Ultrasonics
Hazard
Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. · FDA Class II
Units
118
Sold at
Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
Description
Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.
Product
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Manufacturer(s)
Custom Ultrasonics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →