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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 Duodenoscopessee related information
Date Initiated by FirmDecember 17, 2018
Create DateMarch 12, 2019
Recall Status1 Terminated 3 on November 18, 2020
Recall NumberZ-1008-2019
Recall Event ID 82099
510(K)NumberK051645 
Product Classification Endoscope, accessories, narrow band spectrum - Product Code NWB
ProductOlympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Code Information Serial Number 2418319
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information ContactLaura 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
ActionCustomers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19.
Quantity in Commerce1
DistributionUS Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NWB
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