Z-1182-2008

System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA

Name: Z-1182-2008 System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
Creator: Custom Ultrasonics, Inc.
Published: 2008-02-11
License: https://open.fda.gov/license/

Wassenburg Medical B.V. / initiated 2008-02-11 / Terminated / root cause: labeling and UDI

FDA source

Custom Ultrasonics, Inc. began a recall of System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA on 2008-02-11. The reason FDA records is "Inadvertent selection of the "wash" cycle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1182-2008
Status: Terminated
Initiated: 2008-02-11
Posted: 2008-03-07
Terminated: 2009-09-03
Recalling firm: Wassenburg Medical B.V.
Product: System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
Product code: KOG
Reason for recall: Inadvertent selection of the "wash" cycle
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The recalling firm issued a Product Correction letter dated 2/11/08 to its customers informing them of the problem and the correction choices. The letter states that a key cover is available to reduce the error in the future and will be provided to each users upon return of the recall letter notification questionnaire.
Quantity in commerce: 3,190 units
Distribution: Worldwide; USA medical facilities and physicians and Canada
Product codes and lots: All Serial Numbers

Product code KOG

K983017Class IIModification to System 83 PlusCustom Ultrasonics / cleared 1998-09-22

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)