BF-XT190 bronchovideoscopes recalled for clarified laser and coagulation instructions
Olympus is recalling Bronchovideoscope BF-XT190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The EVIS EXERA Bronchovideoscope Olympus BF-XT190 is being recalled for additional instructions-for-use updates.
The updates provide further clarification on the safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation and high-frequency therapy equipment.
The recall covers 361 units in the United States and 258 outside it, across all serial numbers, UDI 4953170402470. Distribution was nationwide in the United States. The FDA has classified the recall as Class I.
Bronchoscopy units should obtain and follow the updated instructions for use before combining these scopes with the listed energy equipment.
The recalled product
- Product
- EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Bronchoscope
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. BF-XT190
- UDI: 4953170402470
- All Serial No.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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