Recall Z-2292-2020 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
| Date | May 5, 2020 |
| Status | Terminated |
| Reason | Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual. |
| Root cause | 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 in |
| Quantity | 19 |
| Distribution | US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181240 | Rhino-Laryngo Fiberscope Olympus ENF-GP2 Olympus Medical Systems Corp., Oct 4, 2018 |