FDA-Device2013-12-04Class II
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Custom Ultrasonics, Inc.
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.
Sold states
Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
Affected count
118
Manufactured in
144 Railroad Dr, N/A, Ivyland, PA, United States
Products
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0426-2014Don't want to check this manually?
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