Olympus Bronchofiberscope BF-1T60 Receives Updated Reprocessing Instructions Nationwide
Olympus Corporation is issuing updated reprocessing instructions for the BF-1T60 bronchofiberscope to comply with FDA 2015 guidance on device reprocessing in health care settings.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II medical device with no reported illnesses or injuries. This recall represents a precautionary update of reprocessing instructions to comply with FDA 2015 guidance, meeting the criterion for voluntary precautionary recalls.
Plain-English summary
Olympus Corporation of the Americas is issuing validated, new reprocessing instructions for the BF-1T60 OES Bronchofiberscope model, in accordance with FDA 2015 guidance. All 350 units of this device model are affected, with distribution spanning the United States and globally.
Health care facilities using this bronchofiberscope should implement the updated reprocessing instructions provided by Olympus. These instructions detail the validated procedures for preparing the device for clinical use.
Contact Olympus Corporation of the Americas for the complete updated instructions and any additional information regarding this recall.
The recalled product
- Product
- BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 350
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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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