Olympus Bronchofiberscope F-1T160 Recalled for Instrument Channel Port Loosening
Olympus is recalling 3,317 Bronchofiberscope F-1T160 units because using non-Olympus accessories may loosen the instrument channel port.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 involves a structural defect in a medical device that could lead to equipment failure during use. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Olympus Corporation of the Americas is recalling 3,317 units of the Bronchofiberscope F-1T160. The recall was initiated because the attachment of non-Olympus accessories to the bronchoscope's instrument channel port may have resulted in more applied force than expected. This excessive force can lead to the loosening of the instrument channel port.
The affected products were distributed nationwide in the United States and in Canada. The recall includes all lot codes for this specific model.
Healthcare facilities and users should stop using the affected Bronchofiberscope F-1T160 units and contact Olympus Corporation of the Americas for further instructions on how to proceed with the recall.
The recalled product
- Product
- Bronchofiberscope F-1T160
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 3,317
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 lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 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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