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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasound Gastroscopes, Gastroscopes, Colonoscopes and Duodenoscopes

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  Class 2 Device Recall Ultrasound Gastroscopes, Gastroscopes, Colonoscopes and Duodenoscopes see related information
Date Initiated by Firm December 17, 2018
Create Date March 12, 2019
Recall Status1 Terminated 3 on November 18, 2020
Recall Number Z-1007-2019
Recall Event ID 82099
510(K)Number K093395  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Code Information Serial Number 7621683
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms
484-896-5688
Manufacturer Reason
for Recall		 The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19.
Quantity in Commerce 1
Distribution US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
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.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
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