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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Pleuravideoscope, Model LTF160

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 Class 2 Device Recall Olympus Pleuravideoscope, Model LTF160see related information
Date Initiated by FirmMarch 23, 2020
Create DateApril 22, 2020
Recall Status1 Terminated 3 on November 30, 2021
Recall NumberZ-1762-2020
Recall Event ID 85208
510(K)NumberK013617 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductOlympus Pleuravideoscope, Model LTF-160
Code Information All Serial numbers
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		There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn Urgent Medical Device Correction notification letter dated 3/23/20 was sent to customers. Actions to be taken by the user: Our records indicate that your facility has purchased one or more of the above-referenced endoscopes. OLYMPUS requires that you take the following actions: a) Inspect your inventory of operation manuals for the referenced Olympus models and discard the existing ones. b) Exchange them with the updated, enclosed Operation Manuals having an updated system chart indicating compatible endoscope accessories. c) Notify related personnel at your institution that they should stop the combination use of the LTF-160 and LTF-240 and the subject Endo-Therapy accessories. d) Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0066 and provide your contact information as indicated in the portal. e) If you have further distributed this product, identify your customers, forward them this notification including the attachments, and appropriately document your notification process. Olympus regrets any inconvenience caused and fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly at (484)896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at laura.storms@olympus.com.
Quantity in Commerce265 total
DistributionUS Nationwide
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 = GCJ
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