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U.S. Department of Health and Human Services

Class 2 Device Recall Pentax Video Duodenoscope

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  Class 2 Device Recall Pentax Video Duodenoscope see related information
Date Initiated by Firm February 13, 2018
Date Posted February 20, 2018
Recall Status1 Open3, Classified
Recall Number Z-0643-2018
Recall Event ID 79237
510(K)Number K161222  K092710  
Product Classification Duodenoscope and accessories, flexible/rigid - Product Code FDT
Product Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420)

These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.
Code Information All Serial Numbers
Recalling Firm/
Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact Charlie Toms
800-451-5880 Ext. 2064
Manufacturer Reason
for Recall
The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
FDA Determined
Cause 2
Device Design
Action Pentax Medical sent an Urgent Medical Device Correction/Removal letter dated February 7, 2018, to the United States Customers. The consignee letter includes a customer response form and a revised operator manual with the added recommended periodic maintenance. The letter requests the return of the form which includes an accounting of the devices (by serial number) owned by the facility. The firm is to contact the consignee to arrange return of the affected units and to provide loaner devices as needed. For further questions, please call 1 (800) 431-5880 ext. 2064.
Quantity in Commerce 559
Distribution USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District of Columbia.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FDT and Original Applicant = PENTAX MEDICAL
510(K)s with Product Code = FDT and Original Applicant = PENTAX MEDICAL COMPANY