Home / Recalls / Custom Ultrasonics, Inc. / Z-0426-2014

Z-0426-2014 Class II Terminated

Recalled by Custom Ultrasonics, Inc. — Ivyland, PA

Recall Details

Product Type: Devices
Report Date: December 4, 2013
Initiation Date: March 12, 2013
Termination Date: June 26, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 118

Product Description

Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.

Reason for Recall

Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.

Distribution Pattern

Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.

Code Information

Multiple serial numbers