Olympus BRONCHOVIDEOSCOPE Model BF-Q170 Recalled Due to Combustion Risk
Olympus BRONCHOVIDEOSCOPE Model BF-Q170 is recalled nationally due to complaints of endobronchial combustion during therapeutic laser procedures, classified as FDA Class I.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity of 4 per the rubric. The source reports complaints of serious internal burn complications (endobronchial combustion) during device use, but does not report deaths or hospitalizations.
Plain-English summary
Olympus Corporation of the Americas is recalling the BRONCHOVIDEOSCOPE Model BF-Q170, classified as an FDA Class I recall. The device is used in therapeutic bronchoscopy procedures and is distributed nationwide in the United States.
There have been complaints of endobronchial combustion occurring during therapeutic laser procedures performed with this bronchoscope. Endobronchial combustion is a serious complication involving internal burning in the airway during device use.
The recalled product
- Product
- Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1
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 (1)
- All serial numbers BF-Q170 BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 UDI: 04953170342912
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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