Cl II System 83 Plus 2 and System 83 Plus 9 units

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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