# FDA recall Z-3017-2020

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2020-08-31.

## 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.

## 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.

## Distribution

Worldwide distribution - US Nationwide and International.

## Key facts

- **Recall number:** Z-3017-2020
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-31
- **Report date:** 2020-10-07
- **Termination date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3017-2020

## Citation

> AI Analytics. FDA recall Z-3017-2020. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-3017-2020. Source: US FDA. Licensed CC0.

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