Custom Ultrasonics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0426-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 12, 2013

Date Posted: December 4, 2013

Recall Number: Z-0426-2014

Event ID: 65985

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.

Status: Terminated

Product Quantity: 118

Code Information:

Multiple serial numbers

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated