Z-3017-2020Class II

Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All...

Name: Z-3017-2020 Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All...
Creator: Olympus Corporation of the Americas
Published: 2020-08-31
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2020-08-31 / Terminated / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be... on 2020-08-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3017-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Posted: 2020-09-25
Terminated: 2024-02-14
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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 tracheobronchial tree.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: 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 tag: design
FDA 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 replacement product from Olympus will depend on existing inventory. An Olympus representative will inform you of the approximate timing for your return/replacement. 4. In recognition of the need to continue to serve patients, the BF-Q180 may be continued to be used clinically until suitable alternatives are sufficiently available. Olympus recommends continued adherence to the Instructions for Use related to reprocessing. Customers should note that the BF-Q180 has been validated for High Level Disinfection (HLD), Ethylene Oxide Sterilization and Sterrad NX. Clinical support staff is available to answer questions related to all reprocessing procedures. 5. Olympus will reimburse you $10,000 for each returned BF-Q180. 6. Access the Olympus recall portal to indicate that you have received this notification. Go to https ://olympusamerica.com/recall. Enter the recall number Recall-0366 and provide your contact information as indicated in the portal. 7. If you may have further distributed the BF-Q180, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Quantity in commerce: 5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A.
Distribution: Worldwide distribution - US Nationwide and International.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3017-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3017-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-25

Product code EOQ

K061313Class IIEvis Exera 180 SystemOlympus Medical Systems Corporation / cleared 2006-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)