Company: Custom Ultrasonics, Inc.
Date of Enforcement Report:12/4/2013
Class lI:
PRODUCT
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Recall Number Z-0426-2014
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.
RECALLING FIRM/MANUFACTURER
Custom Ultrasonics, Inc., Ivyland, PA on 3/12/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
118
DISTRIBUTION
Nationwide and Internationally
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