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Custom Ultrasonics Recalls
2 recalls on record · December 4, 2013 to July 13, 2016 · Medical Devices
Recalls by year
13
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 13, 2016Medical DevicesFDA
Custom Ultrasonics, Inc. recalls The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible subme
Hazard: To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
December 4, 2013Medical DevicesFDA
Custom Ultrasonics, Inc. recalls Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
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.