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U.S. Department of Health and Human Services

Class 2 Device Recall System 83 Plus 2 Endoscope/Washer/Disinfector

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  Class 2 Device Recall System 83 Plus 2 Endoscope/Washer/Disinfector see related information
Date Initiated by Firm May 06, 2016
Date Posted July 06, 2016
Recall Status1 Terminated 3 on April 18, 2017
Recall Number Z-2130-2016
Recall Event ID 74311
510(K)Number K122117  
Product Classification Washer, cleaner, automated, endoscope - Product Code NVE
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.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Custom Ultrasonics, Inc.
144 Railroad Dr
Ivyland PA 18974-1449
For Additional Information Contact Elizabeth Lazaro
215-364-1477
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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