Z-2130-2016Class II

The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two...

Name: Z-2130-2016 The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two...
Creator: Custom Ultrasonics, Inc.
Published: 2016-05-06
License: https://open.fda.gov/license/

Wassenburg Medical B.V. / initiated 2016-05-06 / Terminated / root cause: manufacturing process

FDA source

Custom Ultrasonics, Inc. began a recall of The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the... on 2016-05-06. FDA classified it as Class II and gives the reason as "To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2130-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-06
Posted: 2016-07-06
Terminated: 2017-04-18
Recalling firm: Wassenburg Medical B.V.
Product: The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
Product code: NVE Washer, Cleaner, Automated, Endoscope
Reason for recall: To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Custom Ultrasonics, Inc. sent an Urgent Medical Device Recall letter dated May 6, 2016, to all affected customers. The letter advised customers not to use the System 83 Plus AERs for cleaning and/or high-level disinfection of duodenoscopes until further notice. In addition, they sent a warning label for customers to affix in a prominent location on the System 83 Plus AER's on or before June 3, 2016 stating the following: "This device is not indicated for reprocessing of duodenoscopes. Do not reprocess any duodenoscopes in this device until further notice. For alternative reprocessing options, please contact the duodenoscope manufacturer." For questions regarding this recall call 215-364-1477.
Quantity in commerce: 2,345 units
Distribution: Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2130-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2130-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

Product code NVE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)