Recall Z-2497-2021 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
| Date | Aug 17, 2021 |
| Status | Terminated |
| Reason | A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk. |
| Root cause | Under Investigation by firm |
| Action | On August 17, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Olympus will repair your unit free of charge. An Olympus representative will contact you to make arrangements for return of your affected bronchoscope. If you have further questions about this recall, please contact laura.storms@olympus.com for additional information. |
| Quantity | 27 globally (21 US) |
| Distribution | US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES The Olympus Optical Co., Jan 31, 2003 |