Recall Z-0426-2014— Custom Ultrasonics, Inc.

Name: FDA recall Z-0426-2014
Creator: U.S. Food and Drug Administration
Published: 2013-03-12

Class II · Terminated

Class II FDA medical device recall by Custom Ultrasonics, Inc., initiated 2013-03-12, terminated 2014-06-26. It names 2 FDA 510(k) clearances: K122172, K983017. Product: Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.. 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: Custom Ultrasonics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-12
Terminated: 2014-06-26
Firm location: Ivyland, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K122172 — SYSTEM 83 PLUSCustom Ultrasonics·cleared 2013-01-25
K983017 — MODIFICATION TO SYSTEM 83 PLUSCustom Ultrasonics·cleared 1998-09-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.