Olympus Bronchovideoscope Models Risk Device Lodging in Airway
Olympus Corporation is recalling 3,949 Bronchovideoscope units nationwide because the endoscope diameter is too large, causing potential lodging in endotracheal tube connectors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a mechanical sizing hazard with no reported injuries or deaths. FDA Class II classification with theoretical risk of device lodging but no documented adverse events justifies Score 3 under the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Olympus Corporation of the Americas is recalling 3,949 Bronchovideoscope units, Models BF-P190 and BF-XP190, distributed nationwide. These devices are identified by UDI-DI numbers 04953170342110, 04953170434983, 04953170342134, and 04953170434990, including all serial numbers of these models.
The devices are being recalled because the endoscope diameter is too large, which causes the device to become lodged in endotracheal tube connectors. This mechanical sizing defect creates a risk of device entrapment during clinical use.
Healthcare facilities and medical professionals currently using these Bronchovideoscope models may be affected. Users of these devices should verify their inventory against the recalled model and serial numbers.
The U.S. Food and Drug Administration has assigned recall number Z-2500-2023 to this action.
The recalled product
- Product
- Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- device-lodging
- sizing-defect
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 (5)
- UDI-DI: 04953170342110
- 04953170434983
- 04953170342134
- & 04953170434990
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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