Olympus Corporation of the Americas Recall 88560
Description: EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Olympus Corporation of the Americas Recall 88560 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2497-2021 |
| Event ID | 88560 |
| Event Description | EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA. |
| Quantity | 27 globally (21 US) |
| Recall 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. |
| Device Classification | 20210929 |
| Device Code Info | 1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060 |
| Center Classification Date | 20210921 |
| Recall Initiation Date | 20210817 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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