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U.S. Department of Health and Human Services

Class 2 Device Recall ENFGP2 RhinoLaryngo Fiberscope

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  Class 2 Device Recall ENFGP2 RhinoLaryngo Fiberscope see related information
Date Initiated by Firm May 05, 2020
Create Date June 08, 2020
Recall Status1 Terminated 3 on September 18, 2020
Recall Number Z-2292-2020
Recall Event ID 85621
510(K)Number K181240  
Product Classification Nasopharyngoscope (flexible or rigid) - Product Code EOB
Product ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Code Information Serial Numbers 2901130 2901567 2901655 2901548 7900416 7900638 7900546 7900590 2901700 2901410 2901456 2901451 2901414 2901435 2901428 2901437 2901624 2901753 2901788 2801008 2801059 2801069 2801072 2801046 2801023 2901343 2801076 2801010 2801009 2801019 2901891 7900545 2801059 TEST1 TEST2 2801072 7900644 2901529 2801051 7900360 7900187 7900362 7900542 7900589 2801008 7900264 2801058 2801007 2801012 7900612 
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact
484-896-5688
Manufacturer Reason
for Recall		 Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
FDA Determined
Cause 2		 Under Investigation by firm
Action On May 5, 2020, the firm distributed Urgent Medical Device Corrective Action letters to affected customers. Customers were informed that their endoscopes were incorrectly repaired and may be missing an O-ring in the battery holder. Customers were asked to take the following actions: 1. Immediately cease use of the affected endoscope. Olympus will repair your unit free of charge and provide a replacement loaner until repairs can be completed. 2. An Olympus representative will contact you to make arrangements for return of your affected endoscope. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0171 and provide your contact information as indicated in the portal. If you require additional information, please contact the firm at (484) 896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at laura.storms@olympus.com.
Quantity in Commerce 19
Distribution US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.
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 = EOB and Original Applicant = Olympus Medical Systems Corp.
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