ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Recall Z-2292-2020 · Posted None
Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeEOB
Date Initiated2020-05-05
Date Terminated2020-09-18
Product Quantity19
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.
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 [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.