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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA Duodenovideoscopes OLYMPUS JF140F

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 Class 2 Device Recall EVIS EXERA Duodenovideoscopes OLYMPUS JF140Fsee related information
Date Initiated by FirmMay 11, 2018
Create DateJune 21, 2018
Recall Status1 Terminated 3 on May 05, 2020
Recall NumberZ-2269-2018
Recall Event ID 79998
510(K)NumberK853585 
Product Classification Endoscopic Video Imaging System/Component, Gastroenterology-Urology - Product Code FET
ProductOlympus JF-140F duodenoscopes (Model NumberJF-140F)
Code Information All
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information ContactLaura Storms
484-896-5000
Manufacturer Reason
for Recall		Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
FDA Determined
Cause 2		Under Investigation by firm
ActionFirm is extending recall to the user level Letters will be sent on May, 11, 2018 via overnight mail to customers Follow-up phone calls to consignees to offer training on new reprocessing instructions No action can be taken with hospitals that are no longer in business
Quantity in Commerce994
DistributionNationwide
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 = FET
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