Z-0192-2024Class I

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS...

Name: Z-0192-2024 EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS...
Creator: Olympus Corporation of the Americas
Published: 2023-10-12
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-10-12 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170 on 2023-10-12. FDA classified it as Class I and gives the reason as "There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0192-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-10-12
Posted: 2023-11-09
Recalling firm: OLYMPUS Corporation of the Americas
Product: EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Product code: NWB Endoscope, Accessories, Narrow Band Spectrum
Reason for recall: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
FDA root cause: Under Investigation by firm
Action: An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 10/12/23 was sent to customers. Actions to be taken by the end user: Our records indicate that your facility has purchased one or more of the affected bronchoscopes. Olympus requests you to take the following actions: 1. Inspect your facility for the referenced devices and ensure all personnel are completely knowledgeable and thoroughly aware of the Warnings in affected bronchoscope s Operation Manual for use with High-frequency therapy equipment and that Olympus high-frequency compatible bronchoscopes are compatible only with Combination equipment list in operation manual. You may continue to use the device according to the existing instructions and warnings contained in the Instruction for Use. 2. Complete the enclosed response form and return to our recall partner, Sedgwick, via Email ([email protected]) or Fax (866-808-1177). For any questions about the acknowledgement form, please call the Sedgwick team at 855-215-5128. 3. If you have further distributed this product outside of your facility, forward them this notification and appropriately document your notification process. Olympus requests that you report to Olympus complaints, including any injuries associated with procedures involving energy devices used with Olympus bronchoscopes. Please report complaints to the Olympus 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 contact me directly at (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.
Quantity in commerce: 32211 devices
Distribution: US Nationwide distribution
Product codes and lots: Model BF-1TH190 UDI-DI: 4953170335181; Model BF-H190 UDI-DI: 4953170335174; Model BF-Q170 UDI-DI: 4953170342912 Model BF-Q190 UDI-DI: 4953170335198

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0192-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0189-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0190-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0191-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0192-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0193-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09
Z-0194-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09

Product code NWB

K121959Class IIEvis Exera III Video SystemOlympus Medical Systems Corp. / cleared 2013-01-10

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)