Recall Z-3017-2020 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchi
| Date | Aug 31, 2020 |
| Status | Terminated |
| Reason | The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes. |
| Root cause | Device Design |
| Action | Olympus Corporation notified direct customer accounts on 08/31/2020 via recall notification letter. Letter states reason for recall, health risk, and action to take. Actions to be taken by customers include the following: 1. Inspect your inventory and identify any BF-Q180 models. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1 to make arrangements to return your BF-Q180 bronchoscope and discuss replacement options. Olympus will issue a Return Material Authorization for you to return any BF-Q180 at no charge. 3. The timing to return your BF-Q180 and receive a re |
| Quantity | 5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A. |
| Distribution | Worldwide distribution - US Nationwide and International. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061313 | EVIS EXERA 180 SYSTEM Olympus Medical Systems Corporation, Aug 31, 2006 |