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Terminated

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

FDA Recall Z-0426-2014 · Posted 2013-11-27

Recalling FirmCustom Ultrasonics, Inc.
Recall StatusTerminated
Product CodeKOG
Date Initiated2013-03-12
Date Terminated2014-06-26
Product Quantity118

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.

Firm Action

A notification letter, dated February 26, 2013, was sent to direct accounts to inform them of the recall and that technicians would visit facilities to replace the Windows 7 operating system with an appropriately validated Windows XP operating system.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122172SYSTEM 83 PLUSCustom Ultrasonics · 2013-01-25K983017MODIFICATION TO SYSTEM 83 PLUSCustom Ultrasonics · 1998-09-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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