Olympus BF-XT160 Bronchovideoscope Reprocessing Instructions Updated for FDA Compliance
Olympus Corporation is issuing updated reprocessing instructions for 293 BF-XT160 bronchovideoscopes to comply with FDA 2015 guidance. Healthcare facilities should implement the new sterilization and disinfection procedures.
What this means for you
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: This Class II medical device recall involves updated reprocessing instructions with no reported illnesses or injuries. The recall is a proactive, corrective action to ensure compliance with FDA guidance, and the hazard of improper sterilization remains theoretical without evidence of patient harm.
Plain-English summary
Olympus Corporation of the Americas is issuing updated reprocessing instructions for the BF-XT160 EVIS EXERA Bronchovideoscope, a medical device used in healthcare settings to visualize the bronchi (airways). This recall affects 293 units with all serial numbers, distributed domestically nationwide and globally.
The firm has issued new, validated reprocessing instructions to comply with FDA 2015 guidance on reprocessing medical devices in healthcare settings. Proper reprocessing is essential for ensuring device safety and preventing potential contamination.
Healthcare facilities using this bronchovideoscope should implement the updated reprocessing instructions provided by Olympus Corporation. Users should follow the new procedures for device reprocessing as established by the firm according to FDA guidelines.
The recalled product
- Product
- BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- improper-sterilization
- infection-risk
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.
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