FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
- Recall number
- Z-2017-2023
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
- Status
- Open, Classified
- Initiated
- 2023-06-08
- Posted
- 2023-07-17
- Terminated
- not on file
- Reason
- There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
- Root cause
- Under Investigation by firm
- Action
- An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 6/8/23 was sent to customers. Actions to be taken by the company: The labelling will be updated to include specificity about laser compatibility, improved instructions regarding patient preparation, and warnings about patient injury and death resulting from incompatible laser use. Actions to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides compatible laser type. 3. Ensure all personnel are completely knowledgeable and thoroughly aware that Olympus laser compatible bronchoscopes are compatible only with Nd: YAG laser or 810 nm diode lasers. 4. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0427 5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Olympus requests that you report complaints, including any injuries associated with laser procedures with Olympus bronchoscopes, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Olympus regrets any inconvenience caused and fully appreciates your cooperation in this matter. Please do not hesitate to call (647) 999-3203 or email: at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
- Quantity
- 9,684 units
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- All serial numbers BF-H190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 UDI: 04953170434754 BF-Q190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 UDI: 04953170335198 BF-XT190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190UDI: 04953170402470 BF-1TH190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 UDI: 04953170434778
- 510(k) numbers
- ["K121959","K183419"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28