Z-0426-2014Class II

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

Name: Z-0426-2014 Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector
Creator: Custom Ultrasonics, Inc.
Published: 2013-03-12
License: https://open.fda.gov/license/

Wassenburg Medical B.V. / initiated 2013-03-12 / Terminated / root cause: software

FDA source

Custom Ultrasonics, Inc. began a recall of Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector on 2013-03-12. FDA classified it as Class II and gives the reason as "Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0426-2014
Classification: Class II
Status: Terminated
Initiated: 2013-03-12
Posted: 2013-11-27
Terminated: 2014-06-26
Recalling firm: Wassenburg Medical B.V.
Product: Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Product code: KOG
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 118
Distribution: Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
Product codes and lots: Multiple serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0426-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0426-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27

Product code KOG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)